Medical Devices; Performance Standard for Diagnostic X-Ray Systems; Amendment

The Food and Drug Administration (FDA) is issuing a final rule that amends the diagnostic x-ray systems performance standard for dental panoramic systems and mammography systems. This rule exempts panoramic dental x-ray units from the requirement that they be manufactured with exposure timers that automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subject to unnecessary radiation due to repeat radiographs. This action also is intended to align the performance standard for mammography systems with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (the MQSA).