K160131

Substantially Equivalent

OEC Elite MiniView

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

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.