Wuxi Hisky Medical Technologies Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | October 1, 2025 |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Co | July 24, 2025 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini78 | June 17, 2025 |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | March 17, 2020 |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | June 22, 2018 |