Data / Medical devices / Automated Radiological Image Processing Software / China
FDA-registered makers of Automated Radiological Image Processing Software in China: 8 establishments
8 establishments in China are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 3 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
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- China
Makers of Automated Radiological Image Processing Software in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shanghai United Imaging Healthcare Co.,ltd. | Shanghai, China | Manufacturer | 5 | May 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing, China | Complaint file establishment, Manufacturer | 3 | July 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Keya Medical Technology Co.,ltd. | Beijing, China | Manufacturer | 1 | June 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Ultrasound (Shanghai) Co., Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan United Imaging Healthcare Co.,Ltd. | Wuhan Hubei, China | 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.