510(k) K253310 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Nov 25, 2025 |
| Received | Sep 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253310
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.