AMX5 AND AMX5D MOBILE X-RAY SYSTEMS— 510(k) K042866
Substantially EquivalentGe 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. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Technologies
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code IZL
view allMore clearances from Ge Healthcare Technologies
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.