510(k) K243253 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Jun 18, 2025 |
| Received | Oct 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243253
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.