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Data / Medical devices / Solid State X-Ray Imager (Flat Panel/Digital Imager) / South Korea

FDA-registered makers of Solid State X-Ray Imager (Flat Panel/Digital Imager) in South Korea: 20 establishments

20 establishments in South Korea are registered with the FDA to make Solid State X-Ray Imager (Flat Panel/Digital Imager) (product code MQB). 16 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in South KoreaWatch these makers
Device
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Product code
MQB
Country
South Korea

Makers of Solid State X-Ray Imager (Flat Panel/Digital Imager) in South Korea

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Rayence Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer30July 31, 2026000api.fda.gov
DRTECH CorporationSeongnam-si Gyeonggi, South KoreaManufacturer13March 20, 2025000api.fda.gov
Vieworks Co., Ltd.Anyang-si Gyeonggi, South KoreaComplaint file establishment, Exporter to the US, Specification developer11June 18, 2026000api.fda.gov
Vieworks Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer11June 18, 2026000api.fda.gov
LG Electronics Inc.Gumi-si Gyeongbuk, South KoreaExporter to the US, Manufacturer8July 22, 2022000api.fda.gov
H&abyzYongin-si Gyeonggi, South KoreaContract manufacturer, Manufacturer4March 6, 2023000api.fda.gov
Samsung Electronics Co., Ltd.Seoul, South KoreaComplaint file establishment, Specification developer4July 20, 2018000api.fda.gov
Samsung Electronics Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer4July 20, 2018000api.fda.gov
Bontech Co., LtdSuwon-si Gyeonggi, South KoreaExporter to the US, Manufacturer3April 23, 2020000api.fda.gov
PixxGen CorporationAnyang-si Gyeonggi, South KoreaManufacturer3June 4, 2021000api.fda.gov
Radisen Co LtdAnyang Gyeonggi, South KoreaComplaint file establishment, Manufacturer2May 13, 2022000api.fda.gov
SG Healthcare Co LtdMoga-myeon, Icheon-si Gyeonggi, South KoreaManufacturer, Repackager or relabeler2July 7, 2017000api.fda.gov
Astel.incYuseong-gu Daejeon, South KoreaManufacturer1August 25, 2021000api.fda.gov
Dentium Co.,ltd(ict Branch)Suwon Gyeonggi, South KoreaManufacturer1June 10, 2020000api.fda.gov
Digiray CorpDaejeon, South KoreaManufacturer1January 15, 2014000api.fda.gov
JPI Healthcare Co., LtdSeoul, South KoreaComplaint file establishment, Exporter to the US, Manufacturer1February 24, 2025000api.fda.gov
Drgem CorporationGwangmyeong-si Gyeongbuk, South KoreaComplaint file establishment, Specification developer0000api.fda.gov
DRGEM Corporation (Gimcheon Factory)Gimcheon-si Gyeongbuk, South KoreaManufacturer0000api.fda.gov
Iray Korea LimitedSeoul, South KoreaContract manufacturer0000api.fda.gov
Vatech Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov

Updated November 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.