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Data / Medical devices / System, Image Processing, Radiological / South Korea

FDA-registered makers of System, Image Processing, Radiological in South Korea: 42 establishments

42 establishments in South Korea are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 34 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Get makers of this device in South KoreaWatch these makers
Device
System, Image Processing, Radiological
Product code
LLZ
Country
South Korea

Makers of System, Image Processing, Radiological in South Korea

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ewoosoft Co., LtdHwaseong-si Gyeonggi, South KoreaManufacturer30July 23, 2024000api.fda.gov
Infinitt Healthcare Co., Ltd.Seoul, South KoreaManufacturer16April 14, 2020000api.fda.gov
Coreline Soft Co., Ltd.Seoul, South KoreaComplaint file establishment, Manufacturer5October 16, 2020000api.fda.gov
3D Industrial Imaging Co., Ltd.Seoul, South KoreaManufacturer4April 10, 2020000api.fda.gov
Cybermed Inc.Daejeon, South KoreaManufacturer4December 16, 2011000api.fda.gov
Samsung Medison Co., Ltd.HONGCHEON-GUN Gangwon, South KoreaManufacturer4August 23, 2024000api.fda.gov
AIRS Medical Inc.Seoul, South KoreaManufacturer3October 27, 2023000api.fda.gov
Claripi Inc.Seoul, South KoreaComplaint file establishment, Manufacturer, Reprocessor, Specification developer3April 6, 2022000api.fda.gov
DRTECH CorporationSeongnam-si Gyeonggi, South KoreaManufacturer3September 23, 2024000api.fda.gov
HDX Will Corp.Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South KoreaManufacturer3December 15, 2021000api.fda.gov
Heuron Co., Ltd.Seoul, South KoreaManufacturer3October 13, 2023000api.fda.gov
JLK, Inc.Gangnam Seoul, South KoreaManufacturer3February 25, 2025000api.fda.gov
LG Electronics Inc.Gumi-si Gyeongbuk, South KoreaExporter to the US, Manufacturer3March 18, 2024000api.fda.gov
Medical Standard Co., Ltd.Songpa-gu Seoul, South KoreaManufacturer3July 7, 2009000api.fda.gov
Rayence Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer3April 30, 2019000api.fda.gov
Samsung Medison Co., Ltd.Gumi-si Gyeongbuk, South KoreaManufacturer3May 15, 2018000api.fda.gov
Neurophet, Inc.Seoul, South KoreaManufacturer2May 10, 2023000api.fda.gov
Ray Co., LtdYongin-si Gyeonggi, South KoreaExporter to the US, Manufacturer2May 21, 2025000api.fda.gov
Vieworks Co., Ltd.Anyang-si Gyeonggi, South KoreaComplaint file establishment, Exporter to the US, Specification developer2November 4, 2025000api.fda.gov
Vieworks Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer2November 4, 2025000api.fda.gov
3D Ons, Inc.Gangnam-gu Seoul, South KoreaManufacturer1May 23, 2022000api.fda.gov
Assemblecircle Corp.Seongnam-si Gyeonggi, South KoreaManufacturer1August 17, 2022000api.fda.gov
Digiray CorpDaejeon, South KoreaManufacturer1August 3, 2015000api.fda.gov
Drgem CorporationGwangmyeong-si Gyeongbuk, South KoreaComplaint file establishment, Specification developer1March 8, 2019000api.fda.gov
DRGEM Corporation (Gimcheon Factory)Gimcheon-si Gyeongbuk, South KoreaManufacturer1March 8, 2019000api.fda.gov
GP&P Co., Ltd.Seoul, South KoreaContract manufacturer, Manufacturer1July 3, 2014000api.fda.gov
Irm Inc.Seoul, South KoreaManufacturer1July 9, 2020000api.fda.gov
JPI Healthcare Co., LtdSeoul, South KoreaManufacturer1March 17, 2017000api.fda.gov
MEDICAL IP Co., Ltd.Seoul, South KoreaManufacturer1November 7, 2019000api.fda.gov
Megagen Implant Co., Ltd. (Seoul Branch)Seoul, South KoreaManufacturer1June 26, 2019000api.fda.gov
Radisen Co LtdAnyang Gyeonggi, South KoreaComplaint file establishment, Manufacturer1August 19, 2022000api.fda.gov
Taeyoung SoftGwacheon-si Gyeonggi, South KoreaManufacturer1January 31, 2025000api.fda.gov
imfoU CO., LTDGuro-gu Seoul, South KoreaManufacturer1September 15, 2011000api.fda.gov
maihub Corp.Gangnam-gu Seoul, South KoreaManufacturer1January 5, 2026000api.fda.gov
Iray Korea LimitedSeoul, South KoreaContract manufacturer0000api.fda.gov
Laon Medi Inc.Gwacheon-si, Gyeonggi-do, South KoreaManufacturer0000api.fda.gov
Medit Corp.Seoul, South KoreaContract manufacturer0000api.fda.gov
Ontact Health Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Siemens Healthineers Ltd.SEONGNAM-SI Gyeonggi, South KoreaSpecification developer0000api.fda.gov
Siemens Healthineers Ltd.Pohang-si Gyeongbuk, South KoreaManufacturer, Specification developer0000api.fda.gov
Vatech Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Vuno Inc.Seoul, 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.