RGC · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.5780
Classification
FDA Product Code
RGC
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 892.5780
Review panel
RA
Medical specialty
Radiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement.