Data / Medical devices / System, X-Ray, Tomography, Computed / China
FDA-registered makers of System, X-Ray, Tomography, Computed in China: 8 establishments
8 establishments in China are registered with the FDA to make System, X-Ray, Tomography, Computed (product code JAK). 6 have a 510(k) clearance or PMA approval on file and 4 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, Tomography, Computed
- Product code
- JAK
- Country
- China
Makers of System, X-Ray, Tomography, Computed in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer, Specification developer | 26 | March 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai, China | Manufacturer | 20 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 18 | August 1, 2025 | 0 | 1 | 0 | api.fda.gov |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 10 | May 16, 2025 | 0 | 7 | 0 | api.fda.gov |
| Neusoft Medical Systems Co., Ltd. | SHENYANG Liaoning, China | Manufacturer | 5 | October 11, 2023 | 0 | 12 | 0 | api.fda.gov |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Complaint file establishment, Manufacturer, Specification developer | 4 | March 23, 2026 | 0 | 4 | 0 | api.fda.gov |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang Liaoning, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qisda Electronics (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 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.