Magnifico Open (100009900); Magnifico MSK ( 100009910)— 510(k) K241133

Substantially Equivalent

Esaote, S.p.A.

FDA 510(k) clearance K241133 for Magnifico Open (100009900); Magnifico MSK ( 100009910), Substantially Equivalent on 2024-06-26. Applicant: Esaote, S.p.A..

Clearance details

Applicant: Esaote, S.p.A.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2024-04-24
Decision date: 2024-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Genova, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.