Data / Medical devices / Generator, High-Voltage, X-Ray, Diagnostic / China
FDA-registered makers of Generator, High-Voltage, X-Ray, Diagnostic in China: 7 establishments
7 establishments in China are registered with the FDA to make Generator, High-Voltage, X-Ray, Diagnostic (product code IZO). 0 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
- Generator, High-Voltage, X-Ray, Diagnostic
- Product code
- IZO
- Country
- China
Makers of Generator, High-Voltage, X-Ray, Diagnostic in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carestream Health, Inc., Global R&D Center | Shanghai, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Healthcare International Company, Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei MT Medical Co.,ltd. | Hefei Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens X-Ray Vacuum Technology Ltd. | Wuxi Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spellman High Voltage Electronics(suzhou Industrial Park)co.,ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Powersite Electric Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iRay Imaging Technology (Haining) Limited | Haining Zhejiang, China | Complaint file establishment, Manufacturer, Specification developer | 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.