510(k) K210982— AMX Navigate

Substantially Equivalent

Ge Medical Systems, LLC

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code IZL
Advisory panel: Radiology
Date received: 2021-04-01
Decision date: 2021-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.