MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150— 510(k) K052805

Substantially Equivalent

Esaote, S.p.A.

FDA 510(k) clearance K052805 for MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150, Substantially Equivalent on 2005-10-17. Applicant: Esaote, S.p.A..

Clearance details

Applicant: Esaote, S.p.A.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2005-10-04
Decision date: 2005-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

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.