Data / Medical devices / System, X-Ray, Stationary / China
FDA-registered makers of System, X-Ray, Stationary in China: 7 establishments
7 establishments in China are registered with the FDA to make System, X-Ray, Stationary (product code KPR). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, X-Ray, Stationary
- Product code
- KPR
- Country
- China
Makers of System, X-Ray, Stationary in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai, China | Manufacturer | 13 | August 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 10 | August 28, 2025 | 0 | 1 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 10 | August 28, 2025 | 0 | 2 | 0 | api.fda.gov |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 6 | November 26, 2025 | 0 | 3 | 0 | api.fda.gov |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Complaint file establishment, Specification developer | 4 | July 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Carestream Health, Inc., Global R&D Center | Shanghai, China | Specification developer | 2 | January 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Orich Medical Equipment (tianjin) Co., Ltd. | Tianjin, China | Manufacturer | 2 | December 2, 2016 | 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.