OEC(R) 9800, OEC(R) 9800 PLUS— 510(k) K111551

Substantially Equivalent

Ge Oec Medical Systems, Inc.

FDA 510(k) clearance K111551 for OEC(R) 9800, OEC(R) 9800 PLUS, Substantially Equivalent on 2011-10-04. Applicant: Ge Oec Medical Systems, Inc..

Clearance details

Applicant: Ge Oec Medical Systems, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2011-06-03
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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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.