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FDA PRODUCT CODE · CLASS II

PGY — Display, Diagnostic Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

DEVICE CLASS
Class II
REGULATION
21 CFR 892.2050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K261213Lg Electronics.Inc · 510k2026-06-12
K252780Shenzhen Beacon Display Technology Co., Ltd. · 510k2025-12-19
K253242Shenzhen Beacon Display Technology Co., Ltd. · 510k2025-10-29
K252030Eizo Corporation · 510k2025-08-28
K243221Eizo Corporation · 510k2024-11-27
K243031Shenzhen Beacon Display Technology Co., Ltd. · 510k2024-10-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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