Data / Medical devices / China / Wuxi Hisky Medical Technologies Co., Ltd.
Wuxi Hisky Medical Technologies Co., Ltd.: FDA-registered device maker in Wuxi Jiangsu, China, 5 510(k) clearances
Wuxi Hisky Medical Technologies Co., Ltd. is registered with the FDA (registration 3016493665) in Wuxi Jiangsu, China. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 1, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016493665
- Address
- Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Wuxi Jiangsu, China, 214135
- Owner or operator
- Wuxi Hisky Medical Technologies Co., Ltd. (10062500)
- Roles
- Manufacturer
- First device listed
- February 4, 2020
- Registered through
- 2027
- Brand names listed
- Confocal Microprobe Imaging System, iLivTouch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2025 | K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | IYN | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. | accessdata.fda.gov |
| July 24, 2025 | K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | OWN | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. | accessdata.fda.gov |
| June 17, 2025 | K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | IYO | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. | accessdata.fda.gov |
| March 17, 2020 | K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | IYO | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. | accessdata.fda.gov |
| June 22, 2018 | K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | IYO | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Confocal Optical Imaging
Updated October 1, 2025. 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.