# K052897: GE Definium Amx 700, Model Amx 700

- Pathway: 510(k) (Special)
- Applicant: General Electric Medical Systems
- Decided: Nov 8, 2005 after 25 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE AMX-4+ Mobile X-ray System: named in the summary without a submission number

## 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

## Recalls of this device
- Dec 21, 2006 · Not classified · Z-0821-2007: When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.

## Indications for use
The Definium AMX 700 X-Ray Unit is indicated for use in generating radiographic images of human anatomy. It is intended for general-purpose diagnostic procedures. It is capable of generating radiographic images on firm or digitally. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K052897
Methodology: https://510kreport.com/methodology