510(k) · Cleared

Recalled · 2006

GE Definium Amx 700, Model Amx 700

K052897510(k) SpecialCleared Nov 8, 200525-day reviewClass II21 CFR 892.1720Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

General Electric Medical Systems · IZL System, X-Ray, Mobile

Cleared on Nov 8, 2005 after a 25-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.

Decided: Nov 8, 2005
Review: 25 days
Class: Class II
Product code: IZL
Recalls: 1
Predicates: 0

7 later devices descend from it, 2 citing it directly.

This deviceK052897 GE Definium Amx 700, Model Amx 700General Electric Medical Systems · 2005
Descendant · cites it directly · 5 of its ownK103476 BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC · 2011 · Recalled
Descendant · 2 generations on · 4 of its ownK142383 Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · Recalled
Descendant · 3 generations on · 3 of its ownK162990 Optima XR240amxGe Medical Systems, LLC · 2016 · Recalled
Descendant · 4 generations on · 2 of its ownK173602 Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · Recalled
Descendant · 5 generations on · 1 of its ownK182234 Optima XR240amxGe Medical Systems, LLC · 2018 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all

K103476BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC · 2011 · cites it directly5descendants
K142383Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · 2 generations on4descendants
K162990Optima XR240amxGe Medical Systems, LLC · 2016 · 3 generations on3descendants
K173602Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · 4 generations on2descendants
K182234Optima XR240amxGe Medical Systems, LLC · 2018 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K052897	GE Definium Amx 700, Model Amx 700	General Electric Medical Systems	2005	—
+1	K103476	BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX	Ge Medical Systems, LLC	2011	8
+2	K142383	Optima XR200amx, Optima XR220amx	Ge Medical Systems, LLC	2014	8
+3	K162990	Optima XR240amx	Ge Medical Systems, LLC	2016	2
+4	K173602	Optima XR240amx, AutoGrid	Ge Medical Systems, LLC	2018	2
+5	K182234	Optima XR240amx	Ge Medical Systems, LLC	2018	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2014	1	0
2016	1	0
2018	2	0
2021	1	0

FIG. 1 — Lineage of K052897, 2005–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IZL device

#1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	GE AMX-4+ Mobile X-ray System Named without a submission number			—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103476	BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX	Ge Medical Systems, LLC	2011	5
K111304	Optima XR120	Ge Medical Systems, LLC	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 21, 2006	Not classified	Z-0821-2007	Other	When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K103476 (Ge Medical Systems, LLC, 2011) has gone furthest, with 5 descendants of its own.

How does its category compare?

All IZL devices

IZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZL

11in 2025

2007high 16 (2022) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZL

153in 2025

2007high 159 (2024) · low 30 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZL

47in 2025

2007high 47 (2025) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZL

27in 2025

2007high 118 (2011) · low 16 (2007)2025

MAUDE reports naming product code IZL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	30	7	16
2008	4	49	0	27
2009	3	125	0	35
2010	3	65	4	75
2011	6	66	6	118
2012	3	83	5	24
2013	0	—	10	17
2014	7	104	4	51
2015	4	88	4	30
2016	6	47	0	33
2017	7	45	0	35
2018	8	47	0	27
2019	9	33	2	40
2020	9	43	1	48
2021	13	48	0	47
2022	16	89	1	32
2023	3	55	6	77
2024	9	159	5	39
2025	11	153	47	27
2026	6	157	5	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052897 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052897: GE Definium Amx 700, Model Amx 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052897

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026