SUPEROPEN 0.35T, MODEL NSM-P035— 510(k) K030918

Name: FDA 510(k) clearance K030918
Creator: U.S. Food and Drug Administration
Published: 2003-04-01

Substantially Equivalent

Neusoft Digital Medical Systems Co., Ltd.

FDA 510(k) clearance K030918 for SUPEROPEN 0.35T, MODEL NSM-P035, Substantially Equivalent on 2003-04-01. Applicant: Neusoft Digital Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Neusoft Digital Medical Systems Co., Ltd.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2003-03-24
Decision date: 2003-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, Liaoning, 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.