510(k) · Cleared
ClearedCMDR 2CW (Multiple models)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minxray, Inc. · IZL System, X-Ray, Mobile
Cleared on Jul 3, 2019 as substantially equivalent to K171353 (Minxray, Inc., 2017) after a 33-day review. Its family tree reaches back 10 generations to 1990. 11 later devices descend from it.
- Decided
- Jul 3, 2019
- Review
- 33 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 22 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- 2 generations backK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
- 1 generation backK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
- This deviceK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
- Descendant · cites it directly · 9 of its ownK200726 AcuityPDRRadmedix, LLC · 2020
- Descendant · 2 generations on · 4 of its ownK201058 Accuvue+Radmedix, LLC · 2020
- Descendant · 3 generations on · 3 of its ownK210919 AcuityDReRadmedix, LLC · 2021
- Descendant · 2 generations on · 2 of its ownK202353 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
- Descendant · 4 generations on · 1 of its ownK214030 Universal DR 1748Konica Minolta Healthcare Americas, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 4 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 3 generations backK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- 2 generations backK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
- 1 generation backK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
- This deviceK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K200726AcuityPDRRadmedix, LLC · 2020 · cites it directly9descendants
- K201058Accuvue+Radmedix, LLC · 2020 · 2 generations on4descendants
- K210919AcuityDReRadmedix, LLC · 2021 · 3 generations on3descendants
- K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020 · 2 generations on2descendants
- K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −4 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −3 | K100449 | Minxray Model CMDR-2S | Minxray, Inc. | 2010 | — |
| −2 | K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray | Minxray, Inc. | 2014 | — |
| −1 | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | 2017 | — |
| 0 (this device) | K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | 2019 | — |
| +1 | K200726 | AcuityPDR | Radmedix, LLC | 2020 | — |
| +2 | K201058 | Accuvue+ | Radmedix, LLC | 2020 | — |
| +3 | K210919 | AcuityDRe | Radmedix, LLC | 2021 | — |
| +2 | K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020 | — |
| +4 | K214030 | Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisSummary page 4…system Regulatory Class: II Product Codes: IZL, MQB, and LLZ. Common/Usual Name: Digital Mobile Diagnostic X-Ray System 2) Equivalent legally marketed device: K171353 Trade/Device Name: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris Regulation Number: 21 CFR 892.1720… | 2017 |
| † | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | 2015 |
| † | K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | 2015 |
| † | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel Detector | 2014 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K200726 (Radmedix, LLC, 2020) has gone furthest, with 9 descendants of its own.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 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?
Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191451: CMDR 2CW (Multiple models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191451
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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