Data / Medical devices / System, Image Processing, Radiological / China
FDA-registered makers of System, Image Processing, Radiological in China: 17 establishments
17 establishments in China are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 7 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, Image Processing, Radiological
- Product code
- LLZ
- Country
- China
Makers of System, Image Processing, Radiological 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 | 11 | September 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 3 | March 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Augment Intelligent Medical System (china) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 2 | September 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Carestream Health, Inc., Global R&D Center | Shanghai, China | Specification developer | 1 | March 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 1 | May 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hinacom Software And Technology, Ltd. | Haidian District Beijing, China | Manufacturer | 1 | July 12, 2013 | 0 | 0 | 0 | api.fda.gov |
| iRay Group | Shanghai, China | Complaint file establishment, Manufacturer, Specification developer | 1 | August 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CHISON Medical Technologies Co., Ltd. | WUXI Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coretronic Projection (kunshan) Corporation | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LG Electronics Nanjing New Technology Co., Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | Shantou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | SHANTOU Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iRay Imaging Technology (Haining) Limited | Haining Zhejiang, 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.