AMX5 AND AMX5D MOBILE X-RAY SYSTEMS— 510(k) K042866

Substantially Equivalent

Ge Healthcare Technologies

FDA 510(k) clearance K042866 for AMX5 AND AMX5D MOBILE X-RAY SYSTEMS, Substantially Equivalent on 2004-11-02. Applicant: Ge Healthcare Technologies.

Clearance details

Applicant: Ge Healthcare Technologies
Product code: Code IZL
Advisory panel: Radiology
Date received: 2004-10-18
Decision date: 2004-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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.