Data / Medical devices / System, X-Ray, Extraoral Source, Digital / South Korea
FDA-registered makers of System, X-Ray, Extraoral Source, Digital in South Korea: 11 establishments
11 establishments in South Korea are registered with the FDA to make System, X-Ray, Extraoral Source, Digital (product code MUH). 9 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, Extraoral Source, Digital
- Product code
- MUH
- Country
- South Korea
Makers of System, X-Ray, Extraoral Source, Digital in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 5 | October 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dexcowin Co., Ltd. | Seoul, South Korea | Manufacturer, Repackager or relabeler | 4 | October 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 3 | September 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ray Co., Ltd | Yongin-si Gyeonggi, South Korea | Manufacturer | 3 | April 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rayence Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 3 | November 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Digiray Corp | Daejeon, South Korea | Manufacturer | 1 | September 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| HDX Will Corp. | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea | Manufacturer | 1 | November 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| PICOPACK Inc. | Daejeon, South Korea | Manufacturer | 1 | October 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Pointimplant Co., Ltd. | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 1 | January 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| Dentium Co.,ltd(ict Branch) | Suwon Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iray Korea Limited | Seoul, 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.