por Kiko Ramos | May 29, 2025 | Equipment analysis
Regulation of medical devices is an essential pillar in ensuring patient safety, medical efficacy and diagnostic quality throughout the healthcare system. All medical devices must meet stringent legal and technical requirements before they can be marketed and used in clinical practice.
In this context, the application of different measures and regulations for the regulation of medical equipment aims to protect users. And, at the same time, to bring confidence to healthcare professionals, transparency to manufacturing processes and traceability throughout the supply chain.
However, it is important to note that certifying a medical equipment is not just another administrative procedure. It is a multidisciplinary process ranging from design and clinical validation to the implementation of quality systems, risk management and post-marketing surveillance.
But what are the different regulations and processes that must be applied to market and use medical devices in clinical practice? In the following article, we provide a complete guide to the regulation of medical equipment and the current legal frameworks, both at national, European and international level.
What are medical devices?
The medical equipment is devices, apparatus or systems used in the prevention, diagnosis, treatment or rehabilitation of diseases and medical conditions. They range from simple medical devices such as syringes or thermometers to complex technologies such as medical equipment, such as magnetic resonance imaging, ultrasound scannersremote monitoring systems or AI software of radiodiagnostics based on artificial intelligence.
Medical devices can be classified into different categories according to their level of risk for the patient and the user, which directly influences the type of regulation and certification that they must comply with.
Regulation of medical devices: The different regulations and processes
Regulation of medical devices varies from country to country or region to region, but in general, all medical devices are regulated in the United States. regulatory frameworks share a common goal: to ensure that the products are safe and effective for clinical use. Below, we review the different regulations and processes:
CE marking in the European context
In order to launch a medical device or medical equipment on the market and be marketed in the European Union, it must be CE marked. The CE marking is the legal requirement that authorizes the marketing of a medical device in the European Union (EU) and the European Economic Area (EEA).
Indicates that the product complies with the provisions of Regulation (EU) 2017/745 on medical devices.the so-called MDR regulationsand can circulate freely within the European market. This regulation came into use in 2017 and replaced the previous Directive 93/42/EEC with the aim of strengthening the safety, traceability and post-market control of devices.
The first step in determining the CE marking process is to carry out the classification of medical equipment according to risk. Depending on the type of riskthe MDR standard defines a level of technical documentation and a regulatory process to ensure access to the European market. Specifically, medical devices are divided into four classes:
- Class ILow risk
- Class IIaModerate risk
- Class IIbHigh risk
- Class IIIVery high risk. Use of critical implantable/invasive devices
What does CE marking imply?
The CE marking is not a seal of quality, but rather a legal compliance indicator at European level. It guarantees that the manufacturer has followed a series of processes that certify the safety and efficacy of the medical device:
- Evaluation of the device according to the legal requirements of MDR regulations.
- The use of the medical device is safe and effective when used as directed.
- Implementation of a adequate quality management system.
- Use of post-marketing surveillance mechanisms and continuous clinical follow-up.
- Assessment by a Notified Body.
FDA Approval in the United States
In the United Statesthe Food and Drug Administration (FDA) is the government agency responsible for the regulation, supervision and authorization of the marketing of medical devices.
It is developed through the Center for Devices and Radiological Health (CDRH)The FDA is an entity that ensures that all medical devices are safe, effective and manufactured according to quality standards before reaching the market. It classifies products into three categories:
- Class ILow risk, subject to general controls.
- Class IIModerate risk, require a 510(k) submission to demonstrate that they are substantially equivalent to another legally marketed device.
- Class IIIHigh risk. Require premarket approval (PMA) with detailed clinical evidence.
Key differences between FDA Approval and CE marking
| Appearance |
FDA (USA) |
EC (EU) |
| Scope |
United States and countries that recognize the FDA |
European Union and countries that accept CE marking |
| Target |
To authorize the marketing of medical devices under the direct supervision of the FDA. |
To certify that the product complies with the safety and performance requirements defined in the MDR Regulation. |
| Approach |
Stricter pre-market assessment |
Evaluation based on manufacturer's conformity |
| Clinical review |
PMA requires clinical trials |
Only Class III requires robust clinical evidence |
| Times |
Long, especially in PMA |
More agile in classes I and IIa |
| Evaluating Agency |
Public agency (FDA) |
Independent Notified Body |
Regulation of medical devices in Spain: The role of the AEMPS
At Spainthe Spanish Agency of Medicines and Health Products (AEMPS) is the body responsible for applying national and European regulations on medical devices. Its main mission is to guarantee the quality, safety, efficacy and correct information of all medical devices marketed or used in the country.
The AEMPS under the Ministry of Health and acts as the competent authority to supervise compliance with Regulation (EU) 2017/745 on medical devices (MDR), as well as other national provisions. In Spain, the legal framework on the regulation of medical devices is articulated in terms of the following. regulations:
- Royal Decree 192/2023, which regulates medical devicesIt is the most recent and complete national regulation on medical devices. It aims to adapt Regulation (EU) 2017/745 to the Spanish legal system.
- Law 29/2006, on guarantees and rational use of medicines and health products.This Law is the general legal framework for everything related to medicines and medical devices in Spain. Although it was born focused on pharmaceuticals, it has been modified and extended to include medical devices.
- Technical guides and procedures issued by the AEMPS itself.The AEMPS regularly issues technical documents, instructions and guides that help manufacturers and economic agents to correctly interpret and comply with the standards.
ISO standards: Standardization and quality control in medical devices
The ISO (International Organization for Standardization) standards are voluntary international standards that establish best practices for the design, production, evaluation and management of products and services.
In the medical devices field, are not a substitute for legislationsuch as MDR regulations in the European context or FDA approval in the United States. However, they are key instruments for demonstrate compliance with regulatory requirements and ensure the safety, efficacy and traceability of the product. The most relevant ISO standards are highlighted below:
ISO 13485:2016 - Quality management systems for medical devices.
It is the most important standard in this sector. It establishes the requirements for a quality management system (QMS) specifically tailored to medical device manufacturers and distributors.
Regulatory application
Not required by lawbut the implementation of an ISO 13485 system makes it easier to obtain CE markingIt reduces errors and demonstrates a commitment to quality and patient safety.
ISO 14971:2019 - Risk management for medical devices.
Establishes a structured framework for identifying, assessing, controlling and monitoring risk related to a medical device throughout its life cycle.
Regulatory application
It is mandatory in the context of the MDR to demonstrate that a thorough risk assessment has been performed. It is closely integrated with the technical documentation and clinical evaluation of the device.
ISO 10993 - Biological evaluation of medical devices
This set of standards addresses the biocompatible tests necessary to ensure that the materials in contact with the human body are non-toxic or provoke adverse reactions.
Regulatory application
These tests are mandatory for all devices that come into direct or indirect contact with the human body. Their compliance is part of the technical dossier submitted for CE marking or FDA approval.
ISO 14155: Human clinical trials of medical devices - Good clinical practice
Establishes the principles and requirements for the design, conduct, recording and presentation of clinical trials made in humans with medical devices.
Regulatory application
It is mandatory for manufacturers conducting prior clinical studies to CE or FDA certification, especially for class III or implantable devices.
ISO 62304: Software for medical devices - Software lifecycle processes
Defines the software development, maintenance and support requirements used as part of a medical device, or what constitutes a Software as a Medical Device (SaMD).
Regulatory application
As a result mandatory for any healthcare software that affects the diagnosis, treatment or monitoring of patients, either standalone or integrated in hardware. This is a key aspect in products such as medical apps, PACS systems or intelligent ultrasound scanners.
Conclusion
Patient safety starts with responsible certification. Regulatory applications are a key aspect of achieving responsible patient safety. safe and effective commercialization in the field of medical devices. Beyond a mere legal requirement, they represent a structured and rigorous process that ensures that medical devices have been designed, evaluated and manufactured under the most stringent quality standards. high standards of quality, safety and efficiency.
Whether under the CE marking framework in Europe, the FDA in the United States or national health authorities such as the AEMPS in Spain, evaluation and certification procedures are indispensable to ensure that technological innovation in the healthcare sector reaches the market in a responsible, efficient and sustainable manner.
Do you need medical equipment? In that case, do not hesitate to contact us and our 4D team will help you choose the best medical device according to the needs of your clinic or hospital.
Contact 4D
Kiko Ramos
CEO of 4D Médica. Expert in marketing and distribution of medical equipment.
por Kiko Ramos | May 8, 2025 | Projects
The cantabrian capercaillie is one of the most emblematic species of the peninsular biodiversity. With the aim of protecting and conserving this endangered species, an interpretation center for this bird and its natural habitat was created in 2006 in Caboalles de Arriba, in the municipality of Villablino de León. The Capercaillie Center is part of the network of Wild Animal Recovery Centers (CRAS) managed by the Natural Heritage Foundation of Castilla y León.
4D Medical has collaborated with the center through a public bidding process, contributing with medical equipment in the area of veterinary radiology. As experts in marketing and distribution of medical equipment, we have also carried out a collaboration with the CRAS in Burgos and Valladolid. In all these projects, 4D has supplied both X-ray equipment for veterinary medicine and protection materials for professionals. Below, we analyze the project, the work of the Capercaillie Center in León and the various medical equipment supplied.
Capercaillie Recovery Center in Leon
The Capercaillie Center is located in Caboalles de Arriba, in the municipality of Vallablino de León.and is part of of the Laciana Valley Biosphere Reserve, an area of high ecological value recognized by UNESCO. This area is home to species such as the The area is included in the Natura 2000 Network as a Special Protection Area for Birds (SPA).
What is the work of the Capercaillie Center?
The center is responsible for presenting the mixed oak forest ecosystem and one of its emblematic species: the Cantabrian capercaillie.. Seeks to provide a thematic exhibition The museum offers the recreation of a "cantadero", a place where the male grouse performs its courtship song, and allows the visitor to listen to the sounds of the forest through large windows that offer views of the natural environment.
In 2025, a new complete renovation of the exhibition with an investment of more than 400,000 euros, financed by FEDER funds and the Diputación de León. The objective is to communicate in a didactic and informative way the characteristics of the capercaillie habitat and the conservation efforts underway.
Featured species at the Capercaillie Center
The Capercaillie Center in Caboalles de Arriba (León) is an interpretation space dedicated to the conservation of the Cantabrian capercaillie and its habitat. In addition to the capercaillie, the center addresses other emblematic species of the Cantabrian Mountains:
- Cantabrian Capercaillie (Tetrao urogallus cantabricus)This is an endangered species and represents the symbol of the center. Aspects of its biology and behavior are presented, as well as the threats it faces.
- Cantabrian brown bear (Ursus arctos)Another emblematic species of the region is the brown bear, which is also in danger of extinction. Its ecological importance and conservation efforts are highlighted.
- Iberian wolf (Canis lupus signatus)It is a key predator in the Cantabrian ecosystems. The center offers information about its ecology and the role it plays in the natural balance.
- Other speciesThe center provides information on other species of local fauna, such as chamois, eagles and Egyptian vultures, which inhabit the forests and mountains of the area.
New Center for the Recovery of Wild Animals (CRAS) in Valsemana
Currently, the construction of a new Wild Animal Recovery Center at the Valsemana estatein the municipality of La Ercina, in León. This center, managed by the Junta de Castilla y León, will be located in a strategic enclave that already houses facilities such as the Capercaillie Breeding Center and the Brown Bear Acclimatization Center.
The creation of CRAS reinforces the commitment to wildlife protection and will provide opportunities for research and training in this area. This new CRAS joins the existing network in Castilla y León, which includes centers in Valladolid, Burgos and Segovia, and reception centers in Zamora and Salamanca. In 2024, these centers cared for more than 8,600 specimens, an increase of 22% over the previous year.
What will the new CRAS offer?
The new center will have specialized facilities for the treatment and rehabilitation of various wildlife species, including:
- Large carnivoresLike the brown bear and the Iberian wolf.
- MesomammalsMedium-sized mammals, such as foxes and badgers.
- Birds of preyEagles, owls and other protected bird species.
Valsemana's CRAS will also feature facilities for necropsies and cause of death studiescontributing to the research and conservation of wildlife in the region. Both centers play a crucial role in the conservation and recovery of endangered species in the Cantabrian Mountain RangeThe project offers environmental education and promotes the biodiversity of the area.
Medical equipment supplied by 4D Médica to the new Capercaillie Center
The recent investment in facilities, technology and medical equipment by the Junta de Castilla y León seeks to improve veterinary care and obtain a faster and more accurate diagnosis of the different species of wildlife treated in the different centers. To achieve this, 4D Médica has collaborated with the new CRAS of Valsemana, contributing different equipment in the area of veterinary radiology:
Digiray's FireCR Spark X-ray imaging system
The FireCR Spark, developed by Digiray, is a digital X-ray reading system designed to provide high resolution images with great speed and flexibility. This equipment is specially designed to meet the demands of the clinical environment, both in human and veterinary medicine.
Main advantages and features
- Sharp and precise imagesIt incorporates an advanced signal capture technology that allows to obtain radiographs with a high level of detail, facilitating more accurate diagnoses.
- Compact and functional designIts light structure and small size allows it to be easily placed on surfaces or mounted on the wall, making the most of the space available in the office or clinic.
- Versatility in the use of cassettesThe FireCR Spark is compatible with different cassette sizes, adapting to a wide range of radiological studies.
- Tailor-made performanceAvailable in different reading speed configurations, allowing to choose the most suitable model according to the workload and the needs of the medical or veterinary center.
- QuantorMed+ software includedThe system is accompanied by QuantorMed+ Imaging software with an intuitive interface, fast processes and unlimited updates. This ensures that the system is always equipped with the latest features and technological improvements.
4D Medical 4D Unix4D X-ray equipment
The 32kW Unix4D equipment is a high-frequency X-ray system designed specifically for the veterinary environment. It combines power, precision and ease of use, offering an efficient tool for diagnostic imaging in animals.
Main advantages and features
- High frequency X-ray generatorWith an output power of 32 kW, it allows a voltage range of 40 to 125 kVp and a current of 25 to 500 mA, adapting to various diagnostic needs.
- Integrated X-ray tubeIt is equipped with a 3,000 RPM rotating anode and a 2.0 x 1.0 mm focal spot, ensuring high quality images.
- 10″ LCD touch screenEasy configuration and control of the equipment through an intuitive interface.
- APR anatomical programIncludes more than 300 pre-programmed anatomical views, optimizing workflow and reducing exposure time.
- Floating table with integrated buckyIt is designed to facilitate patient positioning by means of a self-supporting column and sensor-activated magnetic brakes.
- Manual calibrationIt allows precise adjustments to be made, adapting to the particularities of each study.
- Available configurationsThe Unix4D is available in different power ratings: 4, 8, 10, 12 and 32 kW, as well as in various mechanical configurations, allowing it to be adapted to the specific needs of each veterinary clinic.
Radiation protection equipment plumbed for veterinary use
The X-ray plummet protection equipment are designed to to protect veterinary professionals and auxiliaries from exposure to ionizing radiation. during the performance of radiographic studies on animals. This type of protection includes a variety of garments and accessories made of materials incorporating lead, specifically designed to block or reduce the penetration of lead. X-rays and thus protect the most vulnerable areas of the human body.
Although radiation doses in veterinary radiology are generally low, repeated exposure over time can lead to significant health risks for practitioners if appropriate radiation protection measures are not implemented. safety and radioprotection in clinical practice daily.
With the contribution of these medical teams, better veterinary care and diagnostic accuracy is promoted, which plays a key role in the protection and conservation of the various endangered species in the Cantabrian Mountains area.
Kiko Ramos
CEO of 4D Médica. Expert in marketing and distribution of medical equipment.
por Kiko Ramos | Apr 30, 2025 | Equipment analysis
Computed radiographyalso known as CR (Computed Radiography), is a technique of image diagnosis which represents a transition between conventional radiology and current digital technologies. Instead of using traditional radiographic film, CR uses photoluminescent phosphor plates that store the energy of the X-rays. This energy is then released and converted into a digital image by a laser readout process.
This system makes it possible to digitize radiographic images without the need to completely transform the X-ray service infrastructure. It is therefore considered to be a intermediate solution between analog and direct digital technology (DR). It is especially useful in clinics or centers seeking to modernize their equipment without making investments as high as those required by DR. In turn, computed radiography can also be used to facilitates the storage, archiving, distribution and analysis of images in digital format. Therefore, the use of this diagnostic imaging technology provides a increased workflow efficiency in the medical environment.
In the following article, we discuss how computed radiography works and its workflow, its advantages and limitations, as well as its main uses in clinical practice.
Computed radiography: How does it work?
The operation of the RC is based on the use of reusable imaging plates coated with a phosphorous material that reacts to exposure with X-rays. This method combines laser technology, optical detection and digital processing in a single sequence.
As a result, by means of computed radiography, the following are obtained high quality diagnostic imaging without the need for chemical processes. The procedure consists of the following stages:
- Image captureFirst, the patient is positioned on the medical equipment to begin the scan. The X-ray exposure impacts on a CR plate, also called a cassette, where the energy is stored in the form of electrons trapped in phosphorous crystals.
- Plate readingAfter exposure, the cassette is inserted into a CR reader. This is a device that uses a laser beam to excite the electrons stored on the plate and then release the energy in the form of visible light.
- Conversion of light into digital imageThe light generated is captured by sensors (photomultipliers), which transform it into electrical signals. Using an analog-to-digital converter, these signals are converted into a digital image.
- Visualization and processingThe resulting image is displayed on a workstation, where different parameters can be adjusted. From modifying brightness, contrast and sharpness to adding annotations, measurements or labeling the image.
- Deletion of the plateAfter the process is completed, the plate is completely erased by intense light to remove any residual information. The process is then completed and the plate can be reused in another study.
Clinical workflow in computed radiography
The workflow in a computed radiography environment is systematic and designed to optimize time and ensure patient traceability. Although it is a more agile and efficient system than traditional development, it is not as immediate as direct digital radiology. Below are the different phases of the computed radiography workflow:
- Patient identification and study prescriptionIt starts with the loading of the patient's record in the RIS system (Radiology Information System), where the parameters of the request and the type of study required are defined.
- Image acquisitionThe technician positions the patient and makes the exposure with the CR plate in the cassette, as in a traditional X-ray.
- Digital reading of the cassetteAfter exposure, the cassette is transferred to the CR reader, where the latent image is digitized through the process described above.
- Processing and post-productionThe digital image is processed by specific software, allowing the technical parameters to be adjusted to optimize diagnostic visibility.
- Technical and medical validationThe technician checks the quality of the image before sending it to the radiologist, who will perform the clinical interpretation and generate the diagnostic report.
- Distribution and archiving: Finally, the image is stored in the PACS system (Picture Archiving and Communication System) and is included in the patient's electronic medical record.
Advantages of computed radiography
The adoption of computed radiography systems brings a number of important benefits to both healthcare personnel and medical facilities:
- Reduction in the use of chemicalsDoes not require the use of liquids or developer, which reduces environmental impact and biohazards.
- Reuse of platesPhosphor plates can be reused. Therefore, it offers great economic savings in the medium term.
- Improved image qualityCompared to analog radiology, CR offers better sharpness and digital adjustability.
- Easy integration into existing digital systemsIt can be connected to workstations such as the PACS system, the RIS system or DICOM printers, facilitating the exchange and management of medical information.
- Adaptability to existing equipment: Many installations of old X-rays Traditional or traditional systems can continue to be used with CR systems, which minimizes the initial costs of digitization.
Limitations compared to other techniques
Despite its advantages, computed radiography has certain limitations when compared to more advanced technologies, such as direct digital radiology (DR) systems:
- Increased processing timeThe technician must physically handle the cassette, which lengthens the time between exposure and image display.
- Increased operational burden for technical staffThe reading and handling of the cassettes involves additional steps that do not exist in the DR technique, where the image appears automatically.
- Slightly lower image qualityIn situations where maximum resolution and diagnostic accuracy is required, such as in fine lung studies or mammography, DR usually offers better results.
- Maintenance costs of CR readersAlthough CR technology is more affordable than DR, it requires a specific reader that involves maintenance, calibration and, in some cases, replacement of parts.
What are the differences between computed radiography (CR) and direct digital radiography (DR)?
| Features |
Computed Radiography (CR) |
Direct Digital Radiology (DR) |
| Image capture |
Requires cassette with phosphor plate |
Digital sensor integrated in the equipment |
| Image acquisition time |
Slow (requires scanning of the cassette) |
Immediate (real time image) |
| Equipment handling |
Manual intervention of the technician for each study |
Automated, requiring fewer steps |
| Image quality |
Good, but inferior to DR |
Excellent resolution and detail |
| Cost of implementation |
Moderate, reuses traditional equipment |
High, requires investment in advanced technology |
| Reuse of the detector |
Yes, with erasable phosphor plates |
Yes, with integrated digital sensors |
| Uses |
Centers with progressive transition to the digital environment |
High-demand, fast-flowing hospitals and clinics |
Main uses of computed radiography in clinical practice
Computed radiography (CR) is used both in medical centers, hospitals and clinics as in mobile units. It offers a wide versatility, has a low operating cost and provides high compatibility with conventional equipment. These are its main applications in clinical practice:
General radiology
It is used for routine studies such as X-rays of the chest, abdomen, spine, pelvis and extremities. It is an ideal technique for initial and follow-up examinations.
Emergency and traumatology
In emergency departments, CR allows rapid imaging of fractures, dislocations or bone injuries without the need for chemical processing. It is very useful in the rapid evaluation of polytraumatized patients.
Postoperative control
It is used to verify the correct placement of prostheses, screws or osteosynthesis material after orthopedic surgery, as well as for the evolutionary follow-up of injuries.
Thoracic and pulmonary evaluation
Chest radiography is one of the most frequent applications. It can detect infections, pleural effusions, nodules or signs of heart failure. CR facilitates digital contrast adjustment to improve the visualization of lung structures.
Dentistry and orthodontics
In some centers, computed dental radiography is used for orthopantomography, cephalometric studies or periapical radiographs, especially when compatible digital adapters are available.
Veterinary applications
Many veterinary centers use computed radiography as their primary imaging system because of its economy and ease of use, especially for radiographs of small and large animals.
Mobile units and health campaigns
Because of its portability and ease of installation, computed radiography is used in radiology trucks or mobile units.
Conclusion
Computed radiography is an effective, flexible and versatile medical technique. which has been key in the digitization process of diagnostic imaging services. It offers an efficient alternative for centers that wish to modernize without replacing all their equipment, adapting to multiple clinical environments.
Newer technologies, such as direct digital radiology, provide more automated and streamlined processes. Nevertheless, CR is still a viable alternative that can be used especially in small and medium-sized medical centers, mobile units or services with limited budgets that require a progressive transition to digital systems.
If your clinic needs advice on which computerized, conventional or direct radiography equipment is most suitable for your center, at 4D Médica we have the solution for each particular case. Request information without obligation.
Contact 4D Médica
Bibliography
Vergara E, Mauricio, Sepúlveda R, Gladys, & Vega T, Daniela (2006). RADIOGRAPHIC TECHNIQUE IN COMPUTED RADIOGRAPHY. Revista chilena de radiología, 12(4), 153-156. https://dx.doi.org/10.4067/S0717-93082006000400003
Kiko Ramos
CEO of 4D Médica. Expert in marketing and distribution of medical equipment.
por Kiko Ramos | Apr 4, 2025 | Equipment analysis
The
fluoroscopy is a technique of
diagnostic imaging which uses X-rays to observe the inside of the human body in real time. It is a
type of X-ray that shows the internal structures of the organism in motion.. Unlike conventional X-rays, which generate static medical images, fluoroscopy creates dynamic images to analyze the functioning of different organs, tissues and other internal structures.
During a fluoroscopy, the
fluoroscopea medical equipment that allows visualization of the patient's organs in motion. The dynamic images that are generated are projected on a monitor in video format so that medical professionals can diagnose and evaluate various medical conditions. This procedure is used to
observe the structures and organs in operation. From seeing how the heart beats and how the lungs are inflamed to examining how food moves through the intestine. Therefore, it is very useful in studies of anatomy and physiology, as well as a support technique in certain interventions.
In the following article, we analyze fluoroscopy as a medical technique. From how a fluoroscopy examination is performed, the use of the fluoroscope and its different types to its main medical applications.
Fluoroscopy
Fluoroscopy is a technique that
allows you to see the inside of the body in motion and in real time. It combines X-ray technology, image detectors and digital processing to show what is happening inside the body. To do this, it is necessary to use specific medical equipment: the fluoroscope, also known as a C-arm.
Using continuous or pulsed X-rays, this device generates a set of dynamic images of the different organs, bones, tissues and joints in order to evaluate how certain structures of the body behave during a specific action. The different
functions and parts of an arc in C allow radiological and fluoroscopic images to be taken.
Mainly, this medical equipment is used in a fluoroscopy examination for
analyze the functioning of the organism when swallowing or breathing, as well as inspecting how a contrast liquid flows through the digestive or circulatory system. In turn, the fluoroscope is also used as a
support technique in certain interventionssuch as stenting of blood vessels or cardiac catheterization.
How is a fluoroscopy procedure performed?
Although the visual result of fluoroscopy is a moving image, there is a certain process behind this technology. Understanding how it works is essential to evaluate its usefulness in medical diagnostics. Below, we explain step by step how a fluoroscopic examination is performed:
Patient preparation
In most cases, a very complex preparation is not necessary. Depending on the type of study, the patient will have to follow specific indications, such as fasting or temporarily suspending certain medications. Upon arrival at the medical center, the patient should
taking off clothes, putting on a gown and removing metal objects such as necklaces, watches or belts, as they may interfere with the images.
Fluoroscopy examination
During the procedure,
patient is positioned on a stretcher or standing in front of the fluoroscopethe team in charge of generating the dynamic images by means of the
X-rays. The exploration consists of the following steps:
Administration of contrast medium
In many studies, a contrast medium is used to enhance the visibility of certain areas of the body. This contrast helps to
highlight structures of interestallowing the physician to see with
the functioning of the different organs and tissues more clearly.. This contrast can be administered in different ways, depending on the area to be studied:
- Oral routeIn case the area to be observed is the upper digestive system (esophagus, stomach).
- Intravenous lineWhen the examination is performed to evaluate the blood vessels or internal organs.
- Through a catheterFor bladder or bowel studies.
2. Capture and acquisition of images in real time
Once the contrast has been administered (if necessary), the technician or physician will begin capturing the medical images in real time. Throughout the procedure,
it is important that the individual remains as still as possible.. Movement can distort the images, so the patient's cooperation is essential to obtain accurate results. During this phase, the specialist will be able to evaluate:
- The movement of an organThe diaphragm when breathing or the bladder when emptying.
- The passage of a contrast mediumto identify blockages, leaks or reflux in the digestive or urinary systems.
- The position of medical devicessuch as catheters, pacemakers, screws or prostheses.
- The dynamic function of a jointuseful in traumatology and physiotherapy.
This functional and dynamic approach is what distinguishes fluoroscopy from other imaging techniques, such as radiography or
computed tomography (CT).
3. Medical image analysis
Modern fluoroscopy equipment is equipped with advanced technologies that enhance the
analysis of medical images:
- Digital image processingDigital systems allow you to adjust different elements of the image, such as brightness, contrast, zoom and orientation.
- Recording and archivingThey offer the possibility to document the procedure or to review key sequences.
- On-screen measurementThe technology can be used to calculate lengths, angles or displacements automatically.
- Image overlay (fluoro overlay)It is very useful in image-guided interventions.
In addition, more and more systems are integrating artificial intelligence functions to assist in the automatic detection of anomalies or to improve visual quality in real time. Among the main advantages of using an
AI software is that it increases diagnostic accuracy and facilitates medical decision making.
Duration of a fluoroscopic examination
The duration of the study may vary depending on the type of examination, the area to be explored and the complexity of the procedure. However, in general terms, a fluoroscopy usually lasts
between 30 minutes and one hour. Once the examination is completed, the patient can return home and, in most cases, resume normal activities, unless otherwise instructed by the physician.
The fluoroscope: Types and characteristics
The fluoroscope, also referred to as a C-arm, is the medical equipment used in a fluoroscopic examination. However, there are different
types of fluoroscopes depending on the type of study to be performed and the space available in the clinic or medical center. We can find two modalities and each one has specific characteristics:
| Features |
Full-Size C-Bow |
Mini C-Bow |
| Size |
Large, robust |
Compact, portable |
| Power |
High, for deep structures |
Medium/low, for surface structures |
| Main applications |
Orthopedic, vascular, spine, cardiac surgery |
Extremity surgery, hand, foot, pediatrics |
| Mobility |
Limited, requires more space |
Tall, easy to move and position |
| Complexity of use |
Advanced, requires technical training |
Simple, faster operation |
| Cost |
Higher |
More economical |
Full-Size C-arms
Full-Size C-Arches are designed to cover a wide range of procedures, from the simplest to the most complex.
- Large size: They have a wider field of view and are characterized by a greater ability to adjust to different positions and angles.
- Ample powerX-ray penetration: They provide deeper X-ray penetration, making them ideal for scanning complex structures such as the spine, thorax or pelvis.
- Advanced technologyMany models incorporate advanced technologies, such as 3D reconstruction, surgical navigation and high-resolution image processing.
- Medical applications: This type of arc is common in trauma, neurosurgery, vascular surgery and cardiac surgery operating rooms, where maximum precision and constant visual control are required throughout the procedure.
Mini bows
Mini C-arms are intended for more localized and less invasive procedures.
- Compact size: Their small size is ideal for small operating rooms, outpatient clinics or specialized practices, as they are much easier to transport and handle.
- Procedures of superficial areas of the bodyThese machines are optimized to work on more superficial areas of the body, such as hands, wrists, feet and ankles.
- Sharpness and lower powerAlthough their power is lower compared to full-size models, they offer clear and detailed images of the extremities. Therefore, it is recommended for minor surgeries or low complexity orthopedic interventions.
- Fast and easy operationFluoroscopes of this type are simpler to operate, as they have shorter start-up and positioning times. This improves efficiency in work environments where there is a high flow of patients.
- Medical applicationsMini C-arms are especially useful in extremity surgery, outpatient trauma, hand and foot surgery, minor image-guided procedures and pediatric interventions.
What is fluoroscopy used for? Main medical applications
Fluoroscopy is used in many types of diagnostic imaging procedures. Among its main medical applications, we can highlight:
Examination of the digestive system
One of the most common applications of fluoroscopy is the study of the digestive system. By means of this procedure, the physician can
observe how food or liquid moves through the digestive tract in real time. In this type of diagnostics, a
contrast medium (such as barium) to be able to analyze more clearly the functioning of the esophagus, stomach or intestines.
Main applications
- Gastroesophageal reflux
- Hiatal hernias
- Ulcers or stenosis
- Swallowing disorders (dysphagia)
Cardiovascular system studies
In cardiology and
interventional radiologyfluoroscopy is a key fundamental technique for
visualizing blood flow through the heart and blood vessels. In these studies, fluoroscopy is used to act with greater precision during delicate interventions, reducing risks and complications. In addition, fluoroscopy is used to
iodinated contrast agents that are injected intravenously to generate medical images of different tissues with greater clarity and sharpness.
Main applications
- Cardiac catheterization: Allows to see coronary arteries and detect obstructions.
- Angiography: Visualizes blood vessels in different parts of the body.
- Placement of stents or pacemakers: Fluoroscopy is used to guide the physician during these procedures.
Support in orthopedic surgeries and traumatology.
During
bone or joint surgeryfluoroscopy helps surgeons to
checking the position of pins, screws, prostheses or bone fragments. This allows interventions to be more precise and safe, reducing postoperative complications.
Main applications
- Spine surgeries
- Repair of complex fractures
- Image-guided joint infiltrations
- Arthrography (joint examination with contrast)
Minimally invasive procedures
Fluoroscopy is essential for performing
image-guided procedures in which needles, catheters or probes are inserted into the body without the need for open surgery. By providing a real-time display, it allows
to accurately access the area of interestThis reduces risks and improves the efficiency of the procedure.
Main applications
- Directed biopsies
- Abscess drainage
- Placement of central catheters
- Pain treatments (nerve blocks)
Use in pediatrics
Fluoroscopy, when performed in children, is used with reduced doses and special protocols to ensure its safety. Therefore, in the field of pediatrics, it is of great use for
observe developing bodily functions.
Main applications
- Swallowing or reflux problems in infants
- Urinary tract malformations
- Evaluation of intestinal transit
- Follow-up of pediatric orthopedic surgeries
Functional evaluation of organs
In addition to detecting structures, fluoroscopy allows for the following
see and analyze how certain organs function. In these cases,
not only to detect abnormalities, but also to study how the body works in action.
Main applications
- To analyze how the bladder contracts during urination (cystography).
- Examine how the diaphragm moves when breathing.
- Perform an evaluation of gastric emptying.
The fluoroscopy procedure is a
safe, non-invasive and highly effective technique for observing the body in motion. By combining X-rays and contrast media, medical professionals can obtain clear and accurate images that facilitate diagnosis and clinical decision making.
If you are looking for a fluoroscope for your clinic or hospital and need more information, we help you to choose the medical equipment according to your needs. Contact us and we will answer all your questions.
Contact 4D Médica
Kiko Ramos
CEO of 4D Médica. Expert in marketing and distribution of medical equipment.
por Kiko Ramos | Mar 25, 2025 | Projects
4D Médica has collaborated with the Burgos and Valladolid Wild Animal Recovery Centersproviding medical equipment in the area of image diagnosis in the field of veterinary radiology. At present, in Castilla y León, there are three Wild Animal Recovery Centers (CRAS) in the provinces of Valladolid, Burgos and Segovia and two Wild Animal Reception Centers (CRF) in the provinces of Zamora and Salamanca. All of them are part of the network of wildlife care centers of the Natural Heritage Foundation of Castilla y León.
The CRAS have the primary function is to care for and recover injured wildlife species. with the aim of rehabilitating them and reintroducing them into their natural habitat. According to the Regional Ministry of the Environment, the last year has closed with record figures in the CRAS. Throughout 2024, a total of 8,600 specimens have been cared for in the network, an increase of 22%.
Among the different CRAS of the Community, Burgos and Valladolid are the provinces with the highest percentages of specimens received. According to data from the Junta de Castilla y León, Burgos has a total of 1,402 animals attended and Valladolid has 1,376 animals, representing 28% and 21% of the entries respectively.
The collaboration between 4D Médica and the animal recovery centers in Burgos and Valladolid has arisen through a public bidding by the Junta de Castilla y León (Castilla y León Regional Government). In this project, we have supplied different X-ray equipmentas well as protective equipment for professionals in the veterinary field.
The Burgos and Valladolid Wild Animal Recovery Centers
The Wild Animal Recuperation Centers in Burgos and Valladolid are managed by the Junta de Castilla y León and play a fundamental role in the wildlife protection, conservation and recovery. They are responsible for the care and rehabilitation of injured, sick or vulnerable wildlife, to later reintroduce them into their natural habitat.
The CRAS de Burgos was inaugurated on March 25, 2015. and is located in the town of Albillos, Burgos. Its facilities have more than 16,300 m² within a 47,000 m² plot of land and allow it to take care of a total of 100 birds and 25 mammals simultaneously. It is the largest recovery center in the Community of Castilla y León, making it a reference point for the provinces of Burgos, Palencia and Soria. For its part, the Wild Animal Recovery Center of Valladolid has been working with wildlife since 1989..
What are the main functions of recovery centers?
The CRAS of Burgos and Valladolid play an essential role in the specialized care of wildlife. In turn, they collaborate with institutions and scientific research projects on environmental and biodiversity conservation in the region of Castilla y León. Specifically, they perform the following functions:
Reception, veterinary care and rehabilitation of wild animals
Both centers receive wild animals from citizens, environmental agents or law enforcement agencies, where they undergo a thorough examination of the animals. veterinary diagnosis to identify injuries, wounds or diseases. Once at the center, the animal recovery in order to rehabilitate them and reintroduce them into their natural habitat in the shortest possible time, whenever feasible.
Breeding in captivity of protected or endangered species
They also participate in captive species breeding programs to reinforce wild populations or endangered animal species.
Biodiversity conservation
Contribute to the maintenance and recovery of native species and disease control which can affect wildlife, livestock and the human population, known as zoonoses.
Scientific research and health surveillance
Another of its functions is to collect data on the animals treated and deceased. From the different causes of admission, injuries and pathologies to the study of the evolution of the disease. In the Valladolid and Burgos centers, the following are carried out anatomopathological analysis of deceased specimensThis allows the detection of diseases, intoxications and other crimes against wildlife. These analyses also contribute to genetic censuses of protected species such as the Iberian wolf and the brown bear. At the same time, these centers participate in wildlife health surveillance studies and programs.
Environmental education and awareness
Through outreach activities, school visits or awareness-raising campaignspromote respect, respect for the environmental education and wildlife protection. Among their tasks, they are in charge of informing about the most common causes of entry of wild animals, such as roadkill, electrocution, illegal traps, etc.
Custody of species that cannot be reintroduced into the wild
Some animals cannot return to the wild by the presence of irreversible lesions. Thus, CRAS maintain and care for these animals. in the center and study the evolution of each one of them. for educational and scientific purposes.
Coordination with other entities
Recovery centers collaborate with the Territorial Environmental Service, police forces, research centers and other regional or state administrations. to protect wildlife and rehabilitate animals in need of veterinary care.
Medical equipment supplied by 4D Médica
In collaboration with the CRAS of Burgos and Valladolid, the following have been provided medical devices:
Two Digiray FireCR Spark X-Ray image acquisition systems
The FireCR Spark is a digital radiographic reading system developed by Digiray. This equipment is designed to provide high quality medical images in an efficient and adaptable way to various clinical needs.
Main characteristics:
- High image qualityThe FireCR Spark uses advanced signal collection technology that ensures clear and detailed images, facilitating accurate diagnoses.
- Compact and versatile designThe small size and light weight of the device allows it to be placed on a table or on the wall, optimizing space in clinical environments.
- Support for multiple cassette sizesThe system supports a variety of cassette sizes to suit different imaging needs.
- Adaptive processing speedThe FireCR Spark line offers models with different imaging speeds to meet the specific requirements of veterinary medical diagnostics.
- Advanced softwareQuantorMed+ Imaging software is included, providing an intuitive and easy-to-use interface. It offers fast and efficient operation and unlimited software updates, allowing the system to be kept up to date with the latest enhancements and functionalities.
Neovet X-Ray Equipment
Neovet equipment is a veterinary radiology system developed by the manufacturer Sedecal. It is specifically designed to meet the imaging needs of veterinary clinics and hospitals. This medical equipment combines advanced medical technology with functionalities adapted to the veterinary environment, facilitating high quality imaging for a variety of animal species.
Main characteristics:
- Versatility in different imaging modalitiesThe system offers both analog and digital solutions, adapting to the preferences and requirements of each clinic. In addition, it offers a choice of fixed or variable focal length and the possibility of angular projections, which expands the diagnostic options available.
- Exclusive STII Software (Only 3 Simple Touches)This intuitive software enables optimal digital imaging with as few as three interactions, streamlining the image acquisition process and improving efficiency in the clinical workflow.
- Control console optionsThe system offers three control console configurations to suit different spaces and preferences:
- Embedded tube support
- Pedestal
- Fixed to the wall
- Analog to digital upgrade kitFor clinics that initially opt for a conventional system, Sedecal offers an upgrade kit that converts the Neovet equipment to a digital system, allowing an easy transition to digital radiology and ensuring a good investment for the future.
Biochemistry equipment
A biochemistry team also called a biochemistry analyzer, is an automated device that can be used to analyze measures concentrations of chemicals in biological samples. Mainly blood and urine. These analyses provide information on the functioning of various organs and systems of the animalssuch as the liver, kidneys, pancreas or general metabolism.
Veterinary equipment is adapted to work with species-specific reference values, which is key in animals with very different physiologies. From dogs, cats, and horses to cattle or poultry.
Main functions in veterinary medicine
- Evaluate the liver function.
- Analyze the kidney function.
- Detect metabolic disorders.
- Electrolyte profile studywhere sodium, potassium, calcium and chlorine values are measured.
- Follow-up of treatments or surgeries
- Preventive control and routine check-ups
Hematology team
A hematology team is an automated analyzer that studies the cellular composition of animal blood.. By means of this device, it is possible to perform a complete hemogramadapted to the hematological particularities of different animal species. These devices use technologies such as electrical impedance, flow cytometry or colorimetry to count, classify and measure the characteristics of red blood cells, white blood cells and platelets.
Main functions in veterinary medicine
- Diagnosis of hematological diseases
- Follow-up of chronic or infectious diseases
- Pre-surgical evaluation
- Geriatric check-ups and preventive check-ups
- Rapid evaluations in field environments
Leaded X-Ray protection equipment for veterinarians
The X-ray shielding equipment with plumbed for veterinarians have the function of protect veterinary personnel and auxiliaries from exposure to ionizing radiation. during the performance of radiographic studies on animals. This protective equipment consists of a set of garments and elements made of lead-containing materials, which are designed for block or attenuate X-raysthus protecting the most sensitive organs of the human body.
Although the doses used in veterinary radiology are usually low and localized, cumulative exposure can represent a significant risk if appropriate radioprotection in the clinical environment.
With this medical equipment provided by 4D Médica in the veterinary area, the CRAS of Burgos and Valladolid can improve diagnostic accuracy in the treatment, rehabilitation and reintegration of wild animals treated at both centers.
Kiko Ramos
CEO of 4D Médica. Expert in marketing and distribution of medical equipment.
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