Data / Medical devices / System, Imaging, Pulsed Doppler, Ultrasonic / China
FDA-registered makers of System, Imaging, Pulsed Doppler, Ultrasonic in China: 22 establishments
22 establishments in China are registered with the FDA to make System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN). 19 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- System, Imaging, Pulsed Doppler, Ultrasonic
- Product code
- IYN
- Country
- China
Makers of System, Imaging, Pulsed Doppler, Ultrasonic in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Contract manufacturer, Manufacturer, Specification developer | 106 | October 2, 2026 | 0 | 1 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 73 | May 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 70 | May 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sonoscape Medical Corp. | Shenzhen Guangdong, China | Manufacturer | 24 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sonoscape Medical Corp. | SHENZHEN Guangdong, China | Manufacturer | 24 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| CHISON Medical Technologies Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 15 | May 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | Shantou Guangdong, China | Manufacturer | 11 | March 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shantou Institute Of Ultrasonic Instruments Co., Ltd. | SHANTOU Guangdong, China | Manufacturer | 11 | March 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 9 | December 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Wisonic Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 6 | September 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Delica Medical Equipment Co., Ltd. | SHENZHEN Guangdong, China | Manufacturer | 5 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Beijing Konted Medical Technology Co., Ltd | Beijing, China | Manufacturer | 3 | July 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Hisense Medical Equipment Co.,Ltd. | Qingdao Shandong, China | Manufacturer | 3 | May 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Youkey Medical Co., Ltd. | Foshan Guangdong, China | Complaint file establishment, Manufacturer | 2 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Hisense Medical Co., Ltd. | Qingdao Shandong, China | Manufacturer | 2 | May 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Wuhan United Imaging Healthcare Co.,Ltd. | Wuhan Hubei, China | Manufacturer | 2 | May 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Carbon (shenzhen) Medical Device Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | April 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 1 | May 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Wuxi Hisky Medical Technologies Co., Ltd. | Wuxi Jiangsu, China | Manufacturer | 1 | October 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Tingsn Technology Co., Ltd. | Nanjing 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 | |
| Xian Friendship Medical Electronics Co., Ltd. | Xi'an Shaanxi, 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.