510(k) K230179 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
6440 MyLabX90
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Nov 29, 2023 |
| Received | Jan 23, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230179
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2026 | ESAOTE S.P.A. Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 Completed |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.