510(k) · Cleared

Cleared

Amx-4 Plus Mobile X-Ray System

K021016510(k) TraditionalCleared Jun 17, 200280-day reviewClass II21 CFR 892.1720

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

GE Medical Systems · IZL System, X-Ray, Mobile

Cleared on Jun 17, 2002 as substantially equivalent to K802047 (General Electric Co., 1980) after an 80-day review. Its family tree reaches back 1 generation to 1980. 9 later devices descend from it.

Decided: Jun 17, 2002
Review: 80 days
Class: Class II
Product code: IZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K802047 (1980). 9 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK802047 Amx-IiiGeneral Electric Co. · 1980
This deviceK021016 Amx-4 Plus Mobile X-Ray SystemGE Medical Systems · 2002
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 9 descendants. See all descendants

Descendants cleared per year

2004high 2 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · 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
−1	K802047	Amx-Iii	General Electric Co.	1980	—
0 (this device)	K021016	Amx-4 Plus Mobile X-Ray System	GE Medical Systems	2002	—
+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
2004	1	0
2006	1	0
2011	1	0
2014	1	0
2016	1	0
2018	2	0
2021	2	0

FIG. 1 — Lineage of K021016, 1980–2021Source: 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

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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
*	K802047	Amx-Iii Summary page 1 …ray examinations. Comparison with: AMX-4 Plus Mobile X-ray System is substantially equivalent to the AMX-3 Mobile X-ray System, K802047. Conformance: The AMX-4 Plus Mobile X-ray System will conform to applicable section…	General Electric Co.	1980	—

What descends from it? (9)

4 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
K203782	Nanox Cart X-ray System	Nano-X Imaging, Ltd.	2021	0
K063262	AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic Systems	Virtual Imaging	2006	0
K042866	AMX5 and AMX5D Mobile X-Ray Systems	Ge Healthcare Technologies	2004	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021016: Amx-4 Plus Mobile X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021016

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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