FDA > CDRH > Radiological Health Program > Products and Procedures > Diagnostic X-Ray > Fluoroscopy

Fluoroscopy

• Description
• Uses
• Risks/Benefits
• Information for Patients
• Information for Professionals
• Laws, Regulations & Performance Standards
• Industry Guidance
• Other Resources

Description

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.

Uses

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)

Risks/Benefits

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.

Information for Patients

• RadiologyInfo: The Radiology Information Resource for Patients

Information for Professionals

• Radiation Injuries and Fluoroscopy
• Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-Ray Systems (June 10, 2005)

Laws, Regulations & Performance Standards

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:

1000 - General

1002 - Records and Reports

1003 - Notification of defects or failure to comply

1004 - Repurchase, repairs, or replacement of electronic products

1005 - Importation of electronic products

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 :

1010 - Performance standards for electronic products: general

1020.30 - Diagnostic x-ray systems and their major components

1020.31 - Radiographic equipment (for spot film devices)

1020.32 - Fluoroscopic equipment

Industry Guidance

• Guide for Filing Annual Reports for X-ray Components and Systems [PDF] (July 1980)
• A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use (March 1996)
• Compliance Program GuidanceManual: Field Compliance Testing
  of Diagnostic (Medical) X-ray Equipment (March 15, 2000)
• Routine Compliance Testing Procedures for Diagnostic X-Ray Systems (February 1, 2001)
• Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems (November 21, 2000)
• Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry & FDA (September 5, 2003)
• FDA Issues Amendments to the Federal Radiation Safety Performance Standard for Diagnostic X-Ray Systems (June 2005)
• Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment (May 15, 2008)

Other Resources

• Device Advice: Does the Product Emit Radiation? (July 28, 2006)
• Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation (April 25, 2006)
• Regulated Industry: Reports and Recordkeeping
• CeSub Electronic Submissions Program
• Regulated Industry: Imports & Exports
• Guidance for FDA Staff - Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment
• CDRH Organ Dose handbooks containing reference values of radiation doses absorbed in tissues of patients undergoing representative procedures

Updated May 15, 2008