MRI SYTEMS— 510(k) K113281

Substantially Equivalent

Shenzhen Anke High-Tech Co., Ltd.

FDA 510(k) clearance K113281 for MRI SYTEMS, Substantially Equivalent on 2012-05-17. Applicant: Shenzhen Anke High-Tech Co., Ltd..

Clearance details

Applicant: Shenzhen Anke High-Tech Co., Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2011-11-07
Decision date: 2012-05-17
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.