Wuxi Hisky Medical Technologies Co., Ltd.
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories3
Latest Approval2025-10-01
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | IYN | 2025-10-01 | View |
| 510(k) | 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 | 2025-07-24 | View |
| 510(k) | K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | IYO | 2025-06-17 | View |
| 510(k) | K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | IYO | 2020-03-17 | View |
| 510(k) | K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | IYO | 2018-06-22 | View |
No matching devices.