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 Lg Electronics.Inc, Eizo Corporation and Shenzhen Beacon Display Technology Co., Ltd..
FDA 510(k) Cleared Display, Diagnostic Radiology Devices (Product Code PGY)
About Product Code PGY - Regulatory Context
510(k) Submission Activity
134 total 510(k) submissions under product code PGY since 2014, with 134 receiving FDA clearance (average review time: 62 days).
Submission volume has declined in recent years - 10 submissions in the last 24 months compared to 28 in the prior period.
FDA Review Time
Recent submissions under PGY have taken an average of 71 days to reach a decision - up from 61 days historically. Manufacturers should account for longer review timelines in current project planning.
PGY devices are reviewed by the Radiology panel. Browse all Radiology devices →