← FDA Medical Device Classifications

X-Ray Controls - Radiographic

RCB · Not classified · Unknown

Classification

FDA Product Code
RCB
Device class
Not classified
Regulation
Review panel
Medical specialty
Unknown
Submission type
GMP exempt
N
Life sustaining
Implant
Third-party review

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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