6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is an AI-enabled medical device from Esaote, S.p.A., listed by FDA (510(k), K253288) with a decision date of 2026-04-06. Review panel: Radiology.
| FDA submission number | K253288 |
|---|---|
| Pathway | 510(k) |
| Company | Esaote, S.p.A. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-04-06 |
| Decision | Substantially Equivalent |
| Product code | IYN |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | 2 |
| Regulation number | 892.1550 |
| Review time (calendar days) | 189 |
| Applicant country | IT |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.