Data / Medical devices / System, X-Ray, Mobile / South Korea
FDA-registered makers of System, X-Ray, Mobile in South Korea: 18 establishments
18 establishments in South Korea are registered with the FDA to make System, X-Ray, Mobile (product code IZL). 16 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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- Device
- System, X-Ray, Mobile
- Product code
- IZL
- Country
- South Korea
Makers of System, X-Ray, Mobile in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Samsung Electronics Co., Ltd. | Seoul, South Korea | Complaint file establishment, Specification developer | 6 | October 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 6 | October 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Drgem Corporation | Gwangmyeong-si Gyeongbuk, South Korea | Complaint file establishment, Specification developer | 5 | May 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| DRGEM Corporation (Gimcheon Factory) | Gimcheon-si Gyeongbuk, South Korea | Manufacturer | 5 | May 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Poskom Co., Ltd | Goyang-si Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 5 | February 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| NEUF Inc. | Suncheon-si Jeonnam, South Korea | Manufacturer | 2 | August 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Remedi Inc. | Chuncheon Gangwon, South Korea | Manufacturer | 2 | July 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dexcowin Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | October 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| DK Medical Systems Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 1 | July 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| ECOTRON Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | July 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Gemss Healthcare Co., Ltd. | Gyeonggi, South Korea | Manufacturer | 1 | August 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| H&abyz | Yongin-si Gyeonggi, South Korea | Manufacturer | 1 | August 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| OTOM Co., Ltd. | Gwangju, South Korea | Manufacturer | 1 | July 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Soyee Product, Inc. | KANGNAM-KU, SEOUL Gyeonggi, South Korea | Manufacturer | 1 | July 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | February 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Vsi Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | September 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Drtech Corporation | Seongnam-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FSK Co., Ltd | Gimpo-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.