Data / Medical devices / System, X-Ray, Fluoroscopic, Image-Intensified / South Korea
FDA-registered makers of System, X-Ray, Fluoroscopic, Image-Intensified in South Korea: 6 establishments
6 establishments in South Korea are registered with the FDA to make System, X-Ray, Fluoroscopic, Image-Intensified (product code JAA). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, X-Ray, Fluoroscopic, Image-Intensified
- Product code
- JAA
- Country
- South Korea
Makers of System, X-Ray, Fluoroscopic, Image-Intensified in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gemss Healthcare Co., Ltd. | Gyeonggi, South Korea | Manufacturer | 1 | June 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ECOTRON Co., Ltd. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayence Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SG Healthcare Co Ltd | Moga-myeon, Icheon-si Gyeonggi, South Korea | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.