6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)— 510(k) K253288

Substantially Equivalent

Esaote, S.p.A.

FDA 510(k) clearance K253288 for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85), Substantially Equivalent on 2026-04-06. Applicant: Esaote, S.p.A..

Clearance details

Applicant: Esaote, S.p.A.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2025-09-29
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Genoa, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.