510(k) K261272 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
| Applicant | Esonic Technology (Wuhan) Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Jul 23, 2026 |
| Received | Apr 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261272
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.