OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME— 510(k) K123603

Substantially Equivalent

Ge Healthcare Surgery GE Oec Medical Systems, Inc.

FDA 510(k) clearance K123603 for OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME, Substantially Equivalent on 2013-05-17. Applicant: Ge Healthcare Surgery GE Oec Medical Systems, Inc..

Clearance details

Applicant: Ge Healthcare Surgery GE Oec Medical Systems, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2012-11-21
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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.