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Data / Medical devices / Display, Diagnostic Radiology

Display, Diagnostic Radiology (PGY): 16 FDA-registered makers in 7 countries

16 establishments in 7 countries are registered with the FDA to make Display, Diagnostic Radiology (product code PGY, Class 2, 21 CFR 892.2050). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 138 510(k) clearances under this code, the latest on October 2, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
PGY
Device class
2
Regulation
892.2050
Medical specialty
Radiology

Makers by country

CountryMakers
China5
South Korea3
Japan2
United States2
Taiwan2
Belgium1
Italy1

Makers of Display, Diagnostic Radiology

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Eizo CorporationHAKUSAN Ishikawa, JapanManufacturer22September 1, 2026020api.fda.gov
Nanjing Jusha Display Technology Co., LtdNanjing Jiangsu, ChinaManufacturer15June 9, 2023000api.fda.gov
LG Electronics Inc.Gumi-si Gyeongbuk, South KoreaExporter to the US, Manufacturer11June 12, 2026000api.fda.gov
LG Electronics Nanjing New Technology Co., Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer11June 12, 2026000api.fda.gov
Barco N.V.KORTRIJK West-Vlaanderen, BelgiumManufacturer10August 2, 2024010api.fda.gov
JVCKENWOOD CorporationYokohama-shi Kanagawa, JapanComplaint file establishment, Manufacturer, Specification developer9August 1, 2024000api.fda.gov
Foreseeson Custom Displays, Inc.Anaheim, CA, United StatesComplaint file establishment, Remanufacturer8October 31, 2022000api.fda.gov
Qingdao Hisense Medical Equipment Co.,Ltd.Qingdao Shandong, ChinaManufacturer3November 17, 2022000api.fda.gov
Shenzhen Beacon Display Technology Co., Ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Manufacturer3October 29, 2025000api.fda.gov
Acula Technology CorpLuchu Taoyuan, TaiwanManufacturer2June 13, 2024000api.fda.gov
Diva Laboratories, Ltd.New Taipei City, Taipei-District, 235, TaiwanManufacturer2March 16, 2020000api.fda.gov
Beacon Korea Inc.Seongnam-si Gyeonggi, South KoreaManufacturer1October 25, 2024000api.fda.gov
Barco Inc PortlandPortland, OR, United StatesManufacturer1September 6, 2019000api.fda.gov
Barco S.R.L.Saronno Varese, ItalyContract manufacturer0000api.fda.gov
Barco (Suzhou) Healthcare Technology Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
D&T Inc.Yuseong-gu Daejeon, South KoreaContract manufacturer0000api.fda.gov

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.