OEC Elite MiniView— 510(k) K160131

Name: FDA 510(k) clearance K160131
Creator: U.S. Food and Drug Administration
Published: 2016-06-21

Substantially Equivalent

Ge Hangwei Medical Systems Co., Ltd.

FDA 510(k) clearance K160131 for OEC Elite MiniView, Substantially Equivalent on 2016-06-21. Applicant: Ge Hangwei Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ge Hangwei Medical Systems Co., Ltd.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2016-01-20
Decision date: 2016-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.