Data / Medical devices / Interventional Fluoroscopic X-Ray System / China
FDA-registered makers of Interventional Fluoroscopic X-Ray System in China: 5 establishments
5 establishments in China 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
- China
Makers of Interventional Fluoroscopic X-Ray System in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai, China | Complaint file establishment, Manufacturer | 8 | November 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 3 | November 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 3 | November 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 1 | April 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Siemens Shenzhen Magnetic Resonance Ltd. | SHENZHEN Guangdong, China | Manufacturer | 1 | April 28, 2014 | 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.