AMX-4 PLUS MOBILE X-RAY SYSTEM— 510(k) K021016

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K021016 for AMX-4 PLUS MOBILE X-RAY SYSTEM, Substantially Equivalent on 2002-06-17. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code IZL
Advisory panel: Radiology
Date received: 2002-03-29
Decision date: 2002-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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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.