510(k) K250026 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
| Applicant | Wuxi Hisky Medical Technologies Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Oct 1, 2025 |
| Received | Jan 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250026
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.