K113403

Substantially Equivalent

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

Applicant: GE Medical Systems SCS
Product code: OWB
Advisory panel: Radiology
Date received: 2011-11-17
Decision date: 2012-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

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.