OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION— 510(k) K041931

Substantially Equivalent

Ge Oec Medical Systems, Inc.

FDA 510(k) clearance K041931 for OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION, Substantially Equivalent on 2004-08-26. Applicant: Ge Oec Medical Systems, Inc..

Clearance details

Applicant: Ge Oec Medical Systems, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2004-07-19
Decision date: 2004-08-26
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.