Data / Medical devices / Full Field Digital, System, X-Ray, Mammographic / South Korea
FDA-registered makers of Full Field Digital, System, X-Ray, Mammographic in South Korea: 5 establishments
5 establishments in South Korea are registered with the FDA to make Full Field Digital, System, X-Ray, Mammographic (product code MUE). 5 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
- Full Field Digital, System, X-Ray, Mammographic
- Product code
- MUE
- Country
- South Korea
Makers of Full Field Digital, System, X-Ray, Mammographic in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 3 | January 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Rayence Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | March 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vieworks Co., Ltd. | Anyang-si Gyeonggi, South Korea | Complaint file establishment, Exporter to the US, Specification developer | 2 | May 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vieworks Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | May 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | July 17, 2025 | 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.