NSM-S15 SYSTEM— 510(k) K092237

Substantially Equivalent

Neusoft Medical Systems Co., Ltd.

FDA 510(k) clearance K092237 for NSM-S15 SYSTEM, Substantially Equivalent on 2009-09-09. Applicant: Neusoft Medical Systems Co., Ltd..

Clearance details

Applicant: Neusoft Medical Systems Co., Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2009-07-23
Decision date: 2009-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, 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.