# K021016: Amx-4 Plus Mobile X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jun 17, 2002 after 80 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: 1 generation back to K802047 (1980). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802047: Amx-Iii, General Electric Co. (1980) Summary page 1.

## Most influential descendants
- K103476: BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX (2011), 5 descendants of its own
- K142383: Optima XR200amx, Optima XR220amx (2014), 4 descendants of its own
- K162990: Optima XR240amx (2016), 3 descendants of its own
- K173602: Optima XR240amx, AutoGrid (2018), 2 descendants of its own
- K182234: Optima XR240amx (2018), 1 descendant of its own

## Indications for use
The AMX-4 Plus Mobile X-ray System is 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/K021016
Methodology: https://510kreport.com/methodology