Data / Medical devices / System, X-Ray, Mobile / China
FDA-registered makers of System, X-Ray, Mobile in China: 6 establishments
6 establishments in China are registered with the FDA to make System, X-Ray, Mobile (product code IZL). 6 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
- System, X-Ray, Mobile
- Product code
- IZL
- Country
- China
Makers of System, X-Ray, Mobile in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | Shantou Guangdong, China | Contract manufacturer, Manufacturer | 5 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | SHANTOU Guangdong, China | Contract manufacturer, Manufacturer | 5 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 2 | October 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 1 | June 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 1 | June 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Powersite Electric Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | November 1, 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.