K980322

Substantially Equivalent

ACCENT 16, ACCENT 22

Applicant: GE Medical Systems
Product code: OXO
Advisory panel: Radiology
Date received: 1998-01-27
Decision date: 1998-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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.