OEC Elite— 510(k) K192819

Substantially Equivalent

Ge Oec Medical Systems, Inc.

FDA 510(k) clearance K192819 for OEC Elite, Substantially Equivalent on 2019-11-08. Applicant: Ge Oec Medical Systems, Inc..

Clearance details

Applicant: Ge Oec Medical Systems, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2019-10-01
Decision date: 2019-11-08
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.