510(k) K042866
K042866 is an FDA 510(k) premarket notification submitted by Ge Healthcare Technologies for the device "AMX5 AND AMX5D MOBILE X-RAY SYSTEMS". The FDA issued a decision of Substantially Equivalent on Nov 2, 2004. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Ge Healthcare Technologies has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 2, 2004
- Date Received
- Oct 18, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)