OEC 9900 ELITE— 510(k) K120613

Substantially Equivalent

Ge Healthcare Surgery GE Oec Medical Systems, Inc.

FDA 510(k) clearance K120613 for OEC 9900 ELITE, Substantially Equivalent on 2012-04-06. 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: 2012-02-29
Decision date: 2012-04-06
Decision: Substantially Equivalent
Clearance type: Special
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.