FDA product code · Radiology

X-Ray Field Indicator Light (Laser)

Name: FDA decisions, review times, recalls and adverse event reports for product code RGC
Creator: 510(k) Report

RGCClass I21 CFR 892.5780510(k) exempt0 decisions0 recalls

FDA lists RGC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 892.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, radiology panel

Twenty years of RGC at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — RGC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in RGC? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 892.5780.

IWE Monitor, Patient Position, Light-Beam