510(k) K243880 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
| Applicant | Wuxi Hisky Medical Technologies Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Jun 17, 2025 |
| Received | Dec 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243880
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.