Upgrade Kit MR GUI PRO, MrJ 3300 Plus— 510(k) K192690

Name: FDA 510(k) clearance K192690
Creator: U.S. Food and Drug Administration
Published: 2019-10-24

Substantially Equivalent

Asg Superconductors S.P.A.

FDA 510(k) clearance K192690 for Upgrade Kit MR GUI PRO, MrJ 3300 Plus, Substantially Equivalent on 2019-10-24. Applicant: Asg Superconductors S.P.A.. Device class: 2.

Clearance details

Applicant: Asg Superconductors S.P.A.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2019-09-26
Decision date: 2019-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Genova, IT

Download summary PDF View on FDA.gov ↗

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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.