MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)— 510(k) K242258

Substantially Equivalent

Asg Superconductors S.P.A.

FDA 510(k) clearance K242258 for MROpen Evo (03-2000-00); MROpen Evo (03-4000-00), Substantially Equivalent on 2024-11-26. Applicant: Asg Superconductors S.P.A..

Clearance details

Applicant: Asg Superconductors S.P.A.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2024-07-31
Decision date: 2024-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
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.