SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM— 510(k) K131896

Name: FDA 510(k) clearance K131896
Creator: U.S. Food and Drug Administration
Published: 2014-02-28

Substantially Equivalent

Suzhou Anke Medical System Co., Ltd.

FDA 510(k) clearance K131896 for SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM, Substantially Equivalent on 2014-02-28. Applicant: Suzhou Anke Medical System Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Anke Medical System Co., Ltd.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2013-06-25
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.