PGY

Display, Diagnostic Radiology

Product code
PGY
Device name
Display, Diagnostic Radiology
Device class
Class 2
21 CFR
21 CFR 892.2050
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
17
Summaries archived here
15 (direct download)
510(k) clearances (all years, FDA)
135 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (17)

Last three years. Most recent: 2026-06-12.

NumberDecision dateApplicantDevice nameSummary
K2612132026-06-12Lg Electronics.IncMedical Monitor (40HT513D)PDF
K2527802025-12-19Shenzhen Beacon Display Technology Co.…LCD Monitor (CL1902A, CL2103F)PDF
K2532422025-10-29Shenzhen Beacon Display Technology Co.…LCD Monitor (C1216W, C822W, C821W)PDF
K2520302025-08-28Eizo CorporationRadiForce GX570; RadiForce GX570-ARPDF
K2432212024-11-27Eizo CorporationRadiForce RX570; RadiForce RX570-ARFDA
K2430312024-10-25Shenzhen Beacon Display Technology Co.…LCD Monitors C310S, G310S, C316S, G316S, C616WPDF
K2420082024-08-02Barco N.V.Coronis OneLookPDF
K2411052024-08-01Jvckenwood Corporation3MP Color LCD Monitor (CL-S301)PDF
K2414412024-07-16Eizo CorporationRadiForce RX670; RadiForce RX670-ARPDF
K2414992024-06-13Acula Technology Corp.21.3” 5MP Color LCD Display UMD5-21B01PDF
K2333362024-05-21Acula Technology Corp.21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)PDF
K2403102024-03-29Shenzhen Beacon Display Technology Co.…LCD Monitors C310S, G310S, C316S, G316S, C616WPDF
K2401302024-02-15Lg Electronics.IncMedical Monitor (21HQ613D)FDA
K2338972024-02-06Shenzhen Beacon Display Technology Co.…5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors …PDF
K2334652023-12-21Eizo CorporationRadiForce MX317WPDF
K2336932023-12-11Barco N.V.Nio Color 8MP (MDNC-8132)PDF
K2329852023-12-11Lg Electronics.Inc24HR513CPDF

15 summaries are archived here for direct download.

Official FDA classification page: PGY
Classification and pathway per current FDA publications. Data from openFDA (CC0).