Product Code: RCB FDA not classified

X-Ray Controls - Radiographic

Unknown

X-Ray Controls, Radiographic (product code RCB) is a device that controls input power to x-ray high-voltage generators and/or x-ray tubes for radiographic applications, including timers, phototimers, automatic brightness stabilizers, and similar devices that control x-ray exposure technique factors for generating and recording x-ray patterns to provide images after termination of the exposure. This product is FDA not classified and is regulated under electronic product radiation control authority. It is not GMP exempt and has no associated regulation number or medical specialty.

510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active

Basic Information

Product Code
RCB
Device Class
FDA not classified
Medical Specialty
Unknown

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating and recordingan x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.