510(k) · Cleared

Recalled · 2002

Easy Moving Mobile X-Ray Unit (Model SM-HF)

K012663510(k) TraditionalCleared Aug 31, 200118-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

Sedecal USA, Inc. · IZL System, X-Ray, Mobile

Cleared on Aug 31, 2001 as substantially equivalent to K010304 (Irom Imaging, Inc., 2001) after an 18-day review. Its family tree reaches back 1 generation to 2001. 53 later devices descend from it. It has been recalled once.

Decided: Aug 31, 2001
Review: 18 days
Class: Class II
Product code: IZL
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010304 (2001). 53 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010304 MXR-2000 Mobile X-Ray UnitIrom Imaging, Inc. · 2001
This deviceK012663 Easy Moving Mobile X-Ray Unit (Model SM-HF)Sedecal USA, Inc. · 2001
Descendant · cites it directly · 52 of its ownK043002 Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004
Descendant · cites it directly · 50 of its ownK090322 Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · Recalled
Descendant · 2 generations on · 25 of its ownK142492 GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · Recalled
Descendant · 3 generations on · 24 of its ownK150097 GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · Recalled
Descendant · 4 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2004high 9 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 53 · See all

K043002Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004 · cites it directly52descendants
K090322Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · cites it directly50descendants
K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · 2 generations on25descendants
K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · 3 generations on24descendants
K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010304	MXR-2000 Mobile X-Ray Unit	Irom Imaging, Inc.	2001	—
0 (this device)	K012663	Easy Moving Mobile X-Ray Unit (Model SM-HF)	Sedecal USA, Inc.	2001	—
+1	K043002	Sedecal Mobile X-Ray Units with Digital Detector	Sedecal., Sa.	2004	—
+1	K090322	Easy Moving Plus, SM-XXHF-YY	Sedecal., Sa.	2009	31
+2	K142492	GM60A-32S, GM60A-40S	Samsung Electronics Co., Ltd.	2014	1
+3	K150097	GM60A-32S & GM60A-40S	Samsung Electronics Co., Ltd.	2015	2
+4	K162278	Digital Diagnostic Mobile X-ray System	Samsung Electronics Co., Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2009	1	0
2011	3	0
2013	1	0
2014	2	0
2015	1	0
2016	3	0
2017	3	0
2018	9	0
2019	5	0
2020	2	0
2021	5	0
2022	4	0
2023	3	0
2024	6	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K012663, 2001–2026Source: 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
*	K010304	MXR-2000 Mobile X-Ray Unit Summary page 1 …ommon/Usual Name: Stationary X-Ray System 2. Equivalent legally marketed devices This product is similar in function to the IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT K010304 3. Indications for Use (intended use) The “Easy Moving™" Mobile X-ray Unit (Model SM-HF) is intended for use by a qualified/trai…	Irom Imaging, Inc.	2001	—

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K043002	Sedecal Mobile X-Ray Units with Digital Detector	Sedecal., Sa.	2004	52
K090322	Easy Moving Plus, SM-XXHF-YY	Sedecal., Sa.	2009	50

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 26, 2002	Not classified	Z-650/51-03	Other	Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K043002 (Sedecal., Sa., 2004) has gone furthest, with 52 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 “Easy Moving™” Mobile X-ray unit (Model SM-HF) is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012663 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012663: Easy Moving Mobile X-Ray Unit (Model SM-HF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012663

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026