# K042866: AMX5 and AMX5D Mobile X-Ray Systems

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Technologies
- Decided: Nov 2, 2004 after 15 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K802047 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021016: Amx-4 Plus Mobile X-Ray System, GE Medical Systems (2002) Summary page 1.

## Indications for use
The AMX5 and AMX5D are indicated for use in generating radiographic images of human anatomy in all general purpose X-ray diagnostic procedures. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics, and clinics.

Source page: https://510kreport.com/device/K042866
Methodology: https://510kreport.com/methodology