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Fluoroscopy is a type of medical imaging that shows a continuous x-ray image on a monitor, much like an x-ray movie. It is used to diagnose or treat patients by displaying the movement of a body part or of an instrument or dye (contrast agent) through the body.
During a fluoroscopy procedure, an x-ray beam is passed through the body. The image is transmitted to a monitor so that the body part and its motion can be seen in detail.
Fluoroscopy is used in many types of examinations and procedures. Some examples include
- Barium x-rays and enemas (to view movement through the GI tract)
- Catheter insertion (to direct the placement of a catheter during angioplasty or angiography)
- Blood flow studies (to visualize blood flow to organs)
- Orthopedic surgery (to view fractures and fracture treatments)
Fluoroscopy is a type of x-ray procedure, and it carries the same types of risks as other x-ray procedures. The radiation dose the patient receives varies depending on the individual procedure.
The two major risks associated with fluoroscopy are
- radiation-induced injuries to the skin and underlying tissues (“burns”), and
- the small possibility of developing a radiation-induced cancer some time later in life.
When an individual has a medical need, the benefit of fluoroscopy far exceeds the small cancer risk associated with the procedure. Even when fluoroscopy is medically necessary, it should use the lowest possible exposure for the shortest possible time.
- Radiation Injuries and Fluoroscopy
- Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-Ray Systems (June 10, 2005)
Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.
Manufacturers of fluoroscopy products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:
In addition, fluoroscopy products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1020 :
Because they are medical devices, fluoroscopic equipment must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.
Required Reports for the Fluoroscopy Manufacturers or Industry
Industry Guidance - Documents of Interest
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems FDA Issues Amendments to the Federal Radiation Safety Performance Standard for Diagnostic X-Ray Systems Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
Does the Product Emit Radiation? Getting a Radiation Emitting Product to Market Records and Reporting (Radiation-Emitting Products) Importing and Exporting Electronic Products Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Guidance for FDA Staff CDRH Organ Dose Handbooks