Data / Medical devices / Interventional Fluoroscopic X-Ray System / South Korea
FDA-registered makers of Interventional Fluoroscopic X-Ray System in South Korea: 5 establishments
5 establishments in South Korea are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB). 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
- Interventional Fluoroscopic X-Ray System
- Product code
- OWB
- Country
- South Korea
Makers of Interventional Fluoroscopic X-Ray System in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 6 | April 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | August 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| ECOTRON Co., Ltd. | Seoul, South Korea | Manufacturer | 2 | March 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Gemss Healthcare Co., Ltd. | Gyeonggi, South Korea | Manufacturer | 2 | November 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| SG Healthcare Co Ltd | Moga-myeon, Icheon-si Gyeonggi, South Korea | Manufacturer, Repackager or relabeler | 2 | October 6, 2022 | 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.