FDA Product Code PGY: Display, Diagnostic Radiology
Under FDA product code PGY, diagnostic radiology display systems are cleared for use in clinical image interpretation.
These high-resolution monitors are specifically designed and calibrated for accurate rendering of medical images — including X-ray, CT, MRI, and mammography. They meet stringent luminance, contrast, and uniformity requirements that consumer displays cannot match.
PGY devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Radiology panel.
Leading manufacturers include Eizo Corporation, Lg Electronics.Inc and Wide Corporation.
List of Display, Diagnostic Radiology devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Display, Diagnostic Radiology devices (product code PGY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →