OEC 9900 ELITE— 510(k) K082781

Substantially Equivalent

Ge Healthcare Surgery

FDA 510(k) clearance K082781 for OEC 9900 ELITE, Substantially Equivalent on 2009-05-01. Applicant: Ge Healthcare Surgery.

Clearance details

Applicant: Ge Healthcare Surgery
Product code: Code OWB
Advisory panel: Radiology
Date received: 2008-09-22
Decision date: 2009-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.