510(k) K253288 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253288
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.