K193116

Substantially Equivalent

MRopen EVO

Applicant: Asg Superconductors S.P.A.
Product code: LNH
Advisory panel: Radiology
Date received: 2019-11-12
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Genova, IT

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.