510(k) K905653— ADVANTX AFM ANGIO SYSTEM S1808

Substantially Equivalent

GE Medical Systems

Clearance details

Applicant: GE Medical Systems
Product code: Code IZI
Advisory panel: Radiology
Date received: 1990-12-18
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.