RGC — X-Ray Field Indicator Light (Laser) Class I
FDA product code RGC covers "X-Ray Field Indicator Light (Laser)", a Class I medical device regulated under 21 CFR 892.5780. Submissions are reviewed by the Radiology panel.
Classification Details
- Product Code
- RGC
- Device Class
- Class I
- Regulation Number
- 892.5780
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.