FDA product code RGC: X-Ray Field Indicator Light (Laser)
RGC is the FDA product code for x-ray field indicator light (laser). It is a Class I device, regulated under 21 CFR 892.5780 and reviewed by the Radiology panel. Devices under RGC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | X-Ray Field Indicator Light (Laser) |
| Device class | Class I |
| Regulation | 21 CFR 892.5780 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for RGC devices
openFDA lists no recalls for product code RGC.
Frequently asked questions
What is FDA product code RGC?
RGC is the FDA product code for x-ray field indicator light (laser). It is a Class I device, regulated under 21 CFR 892.5780 and reviewed by the Radiology panel.
What device class is RGC?
Class I, regulation 21 CFR 892.5780. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code RGC
- Run a recall and safety report across every RGC manufacturer
- Watch product code RGC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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