SUPERNOVA C5 MRI SYSTEM— 510(k) K131737

Substantially Equivalent

Liaoning Kampo Medical System Co., Ltd.

FDA 510(k) clearance K131737 for SUPERNOVA C5 MRI SYSTEM, Substantially Equivalent on 2014-10-23. Applicant: Liaoning Kampo Medical System Co., Ltd..

Clearance details

Applicant: Liaoning Kampo Medical System Co., Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2013-06-13
Decision date: 2014-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benxi, Liaoning, CN

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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.