PGYClass II

Display, Diagnostic Radiology

Radiology · 21 CFR 892.2050

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

MDR events1All time

Recalls6All time

Registered firms132Currently listed

510(k) clearances135All time

Recent MDR events

1 adverse event reports on file

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MDRC-1119 WITH PROTECTIVE COVER KITFeb 27, 2017
MalfunctionBarco Nv9613188-2017-00002

Event type breakdown

Malfunction1

Most-reported manufacturers

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Barco Nv1

Recalls

6 recall events for this product code

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Eizo Corporation
TerminatedJul 16, 2015
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752.
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Z-2087-2015 · View FDA record ↗
Eizo Corporation
TerminatedJul 16, 2015
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203.
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Z-2088-2015 · View FDA record ↗
Eizo Corporation
TerminatedJul 16, 2015
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180.
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Z-2089-2015 · View FDA record ↗
Barco N.V.
TerminatedUnknown
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
Z-1172-2021 · View FDA record ↗
Eizo Corporation
Open, ClassifiedUnknown
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-fie
Under certain conditions, a marble pattern infrequently appears on the monitor.
Z-2293-2020 · View FDA record ↗
Eizo Corporation
Open, ClassifiedUnknown
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis
Under certain conditions, a marble pattern infrequently appears on the monitor.
Z-2294-2020 · View FDA record ↗

Registered firms

132 firms currently registered for this product code

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Jvckenwood Corporation
Yokohama-shi Kanagawa, JP
Barco N.v.
KORTRIJK West-Vlaanderen, BE
Qingdao Hisense Medical Equipment Co.,ltd.
Qingdao Shandong, CN
Heager Gmbh
HAAN North Rhine-Westphalia, DE
D&t Inc.
Yuseong-gu Daejeon, KR
Lg Electronics Inc.
Gumi-si Gyeongbuk, KR
Eizo Corporation
HAKUSAN Ishikawa, JP
Nanjing Jusha Display Technology Co., Ltd
Nanjing Jiangsu, CN
Double Black Imaging Corporation
Louisville, CO, US
Lg Electronics Nanjing New Technology Co., Ltd.
Nanjing Jiangsu, CN

510(k) clearances

135 clearances for this product code

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Lg Electronics.IncJun 12, 2026
K261213 · Medical Monitor (40HT513D)
Shenzhen Beacon Display Technology Co., Ltd.Dec 19, 2025
K252780 · LCD Monitor (CL1902A, CL2103F)
Shenzhen Beacon Display Technology Co., Ltd.Oct 29, 2025
K253242 · LCD Monitor (C1216W, C822W, C821W)
Eizo CorporationAug 28, 2025
K252030 · RadiForce GX570; RadiForce GX570-AR
Eizo CorporationNov 27, 2024
K243221 · RadiForce RX570; RadiForce RX570-AR
Shenzhen Beacon Display Technology Co., Ltd.Oct 25, 2024
K243031 · LCD Monitors C310S, G310S, C316S, G316S, C616W
Barco N.V.Aug 2, 2024
K242008 · Coronis OneLook
Jvckenwood CorporationAug 1, 2024
K241105 · 3MP Color LCD Monitor (CL-S301)