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, Nanjing Jusha Display Technology Co., Ltd. and Jvckenwood Corporation.