510(k) · Cleared

Cleared

Minxray, Model CMDR-1S and CMDR-1S-Mil

K082627510(k) TraditionalCleared Nov 7, 200859-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

Minxray, Inc. · IZL System, X-Ray, Mobile

Cleared on Nov 7, 2008 as substantially equivalent to K042361 (Sedecal USA, Inc., 2004) after a 59-day review. Its family tree reaches back 5 generations to 1998. 15 later devices descend from it.

Decided: Nov 7, 2008
Review: 59 days
Class: Class II
Product code: IZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K981556 (1998). 7 ancestors in all. 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
1 generation backK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
This deviceK082627 Minxray, Model CMDR-1S and CMDR-1S-MilMinxray, Inc. · 2008
Descendant · cites it directly · 14 of its ownK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
Descendant · 2 generations on · 13 of its ownK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
Descendant · 3 generations on · 12 of its ownK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
Descendant · 4 generations on · 11 of its ownK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
Descendant · 5 generations on · 9 of its ownK200726 AcuityPDRRadmedix, LLC · 2020

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2010high 4 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 15 · See all

K100449Minxray Model CMDR-2SMinxray, Inc. · 2010 · cites it directly14descendants
K141885CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014 · 2 generations on13descendants
K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017 · 3 generations on12descendants
K191451CMDR 2CW (Multiple models)Minxray, Inc. · 2019 · 4 generations on11descendants
K200726AcuityPDRRadmedix, LLC · 2020 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K981556	Canon X-Ray Digital Camera Cxdi-11	Canon USA, Inc.	1998	—
−4	K992547	Canon X-Ray Digital Camera, Model Cxdi-22	Canon USA, Inc.	1999	—
−3	K023750	Cannon Digital Radiography Model Cxdi-40G	Canon USA, Inc.	2002	—
−2	K031447	Canon, Digital Radiography, Model Cxdi-50G	Canon, Inc.	2003	—
−1	K042361	Digital Portable X-Ray Units, Model SP-HF-4.0 D	Sedecal USA, Inc.	2004	—
0 (this device)	K082627	Minxray, Model CMDR-1S and CMDR-1S-Mil	Minxray, Inc.	2008	—
+1	K100449	Minxray Model CMDR-2S	Minxray, Inc.	2010	—
+2	K141885	CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray	Minxray, Inc.	2014	—
+3	K171353	CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris	Minxray, Inc.	2017	—
+4	K191451	CMDR 2CW (Multiple models)	Minxray, Inc.	2019	—
+5	K200726	AcuityPDR	Radmedix, LLC	2020	—

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
2010	1	0
2014	1	0
2017	1	0
2019	1	0
2020	4	0
2021	2	0
2022	1	0
2023	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K082627, 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

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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
*	K042361	Digital Portable X-Ray Units, Model SP-HF-4.0 D Summary page 1 …te X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital Mobile Diagnostic X-Ray System 3. Equivalent legally marketed device: 510(k) Number K042361 DIGITAL PORTABLE X- RAY UNITS, MODEL SP-HF-4.0 D, SEDECAL USA, INC 4. Indications for Use (intended use) This digital radiogr…	Sedecal USA, Inc.	2004	—
†	K040046	Minxray, Model HF120/60H Powerplus	Minxray, Inc.	2004	—
†	K031447	Canon, Digital Radiography, Model Cxdi-50G	Canon, Inc.	2003	—

Also cleared against K042361: 1 other device →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100449	Minxray Model CMDR-2S	Minxray, Inc.	2010	14

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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K100449 (Minxray, Inc., 2010) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate K042361.

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. 2008, this device’s year, is highlighted.

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?

This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays..

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082627: Minxray, Model CMDR-1S and CMDR-1S-Mil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082627

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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