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

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..

Clearance details

Applicant: Suzhou Anke Medical System Co., Ltd.
Product code: Code LNH
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 ↗

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.