510(k) · Cleared

Cleared

Digital Portable X-Ray Units, Model SP-HF-4.0 D

K042361510(k) SpecialCleared Sep 29, 200429-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

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

Cleared on Sep 29, 2004 as substantially equivalent to K020436 (Sedecal., Sa., 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1998. 22 later devices descend from it.

Decided: Sep 29, 2004
Review: 29 days
Class: Class II
Product code: IZL
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K981556 (1998). 6 ancestors in all. 22 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
3 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
2 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
1 generation backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
This deviceK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
Descendant · cites it directly · 15 of its ownK082627 Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc. · 2008
Descendant · 2 generations on · 14 of its ownK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
Descendant · 3 generations on · 13 of its ownK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
Descendant · 4 generations on · 12 of its ownK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
Descendant · 5 generations on · 11 of its ownK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008high 4 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 22 · See all

K082627Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc. · 2008 · cites it directly15descendants
K100449Minxray Model CMDR-2SMinxray, Inc. · 2010 · 2 generations on14descendants
K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014 · 3 generations on13descendants
K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017 · 4 generations on12descendants
K191451CMDR 2CW (Multiple models)Minxray, Inc. · 2019 · 5 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K981556	Canon X-Ray Digital Camera Cxdi-11	Canon USA, Inc.	1998	—
−3	K992547	Canon X-Ray Digital Camera, Model Cxdi-22	Canon USA, Inc.	1999	—
−2	K023750	Cannon Digital Radiography Model Cxdi-40G	Canon USA, Inc.	2002	—
−1	K031447	Canon, Digital Radiography, Model Cxdi-50G	Canon, Inc.	2003	—
0 (this device)	K042361	Digital Portable X-Ray Units, Model SP-HF-4.0 D	Sedecal USA, Inc.	2004	—
+1	K082627	Minxray, Model CMDR-1S and CMDR-1S-Mil	Minxray, Inc.	2008	—
+2	K100449	Minxray Model CMDR-2S	Minxray, Inc.	2010	—
+3	K141885	CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray	Minxray, Inc.	2014	—
+4	K171353	CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris	Minxray, Inc.	2017	—
+5	K191451	CMDR 2CW (Multiple models)	Minxray, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2012	1	0
2014	1	0
2017	1	0
2018	2	0
2019	2	0
2020	4	0
2021	2	0
2022	2	0
2023	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K042361, 1998–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K020436	Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0 Our OCR of the scanned summary read K020435, FDA’s number for Wound Protector/Retractor (Applied Medical Resources Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sedecal Portable X-Ray Units”.	Sedecal., Sa.	2002	1
*	K031447	Canon, Digital Radiography, Model Cxdi-50G Summary page 1 …me: Portable general purpose diagnostic X-ray Unit. 2. Equivalent legally marketed devices: Sedecal Portable X-Ray Units K020435 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units, 3. Indications for Use (intended use) The Sedecal Portable X-ray Units with Dete…	Canon, Inc.	2003	—

Also cleared against K020436: 1 other device →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K082627	Minxray, Model CMDR-1S and CMDR-1S-Mil	Minxray, Inc.	2008	15
K121410	Dragon LW	Sedecal., Sa.	2012	5

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?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K082627 (Minxray, Inc., 2008) has gone furthest, with 15 descendants of its own.
1 other device also cites its predicate K020436.

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?

Sedecal Portable X-Ray Units with Detector are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

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/K042361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042361: Digital Portable X-Ray Units, Model SP-HF-4.0 D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042361

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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