Chison Medical Technologies Co., Ltd.
Manufacturer and brand owner in Wuxi, Jiangsu, China. 5 device types, 35 products catalogued, 11 clearances.
Chison Medical Technologies Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Transducer, Ultrasonic, Diagnostic, System, Image Processing, Radiological and 3 other device types. 35 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | CHISON Medical Technologies Co., Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004753388 |
| FEI number | 3004753388 |
| DUNS | 544914187 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 无锡祥生医疗科技股份有限公司 |
|---|---|
| Source | EMIS company database |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | No.3 Changjiang South Road, Xinwu District |
| Postal code | 214028 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | Sherlock 3CG+ Tip Confirmation System (TCS) | 2019 | 5 |
| System, Image Processing, Radiological | Class 2 | Medical image management and processing system,SiteRite™ 9 Ultrasound System, SiteRite™ 9 Ultrasound System, Diagnostic Ultrasound Transducer,SiteRite™ 9 Ultrasound System | 2024 | 16 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | SonoBook 3, SonoBook 8, SonoBook 9, SonoBook 2, SonoBook 4, L10i-V,L8M5-V,L18-V,R7-V,CW2-V,VC4-V,T5-V,E6-V,E7W-V,E7MW-V and 47 more | 2013 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | SonoBook 3, SonoBook 8, SonoBook 9, SonoBook 2, SonoBook 4, L10i-V,L8M5-V,L18-V,R7-V,CW2-V,VC4-V,T5-V,E6-V,E7W-V,E7MW-V and 50 more | 2013 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | the Viamo C100 (TUS-VC100) transducers, SonoBook 3, SonoBook 8, SonoBook 9, SonoBook 2, SonoBook 4 and 51 more | 2013 | 44 |
Own-Brand Listings
Clearances
11 clearances name Chison Medical Technologies Co., Ltd. as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253949 | 2026-05-22 | IYN | Traditional | This company |
| K233697 | 2024-08-09 | IYN | Traditional | This company |
| K223570 | 2023-03-31 | IYN | Traditional | This company |
| K202457 | 2021-04-29 | FXX | Traditional | This company |
| K201965 | 2021-03-02 | IYN | Traditional | This company |
| K201967 | 2021-02-26 | IYN | Traditional | This company |
| K201968 | 2021-02-26 | IYN | Traditional | This company |
| K201969 | 2021-02-25 | IYN | Traditional | This company |
| K201971 | 2021-02-25 | IYN | Traditional | This company |
| K200780 | 2020-08-05 | IYN | Traditional | This company |
| K180974 | 2018-08-17 | IYN | Traditional | This company |
| K170870 | 2017-07-06 | IYN | Traditional | Chison Medical Imaging Co., Ltd. |
| K170374 | 2017-06-06 | IYN | Traditional | Chison Medical Imaging Co., Ltd. |
| K162172 | 2016-09-14 | IYN | Traditional | Chison Medical Imaging Co., Ltd. |
| K150861 | 2015-07-28 | IYN | Traditional | Chison Medical Imaging Co., Ltd. |
| K131305 | 2013-08-01 | IYN | Traditional | Chison Medical Imaging Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | Cart-based ultrasound systems, Portable ultrasound systems, Handheld ultrasound systems |
| Certifications | CMD, CE, FDA, CSA, KFDA |
| Export markets | 100+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.