510(k) · Cleared

Cleared

Cpi Rad Vision, Model VZW2944XX-YY

K083224510(k) TraditionalCleared Mar 24, 2009141-day reviewClass II21 CFR 892.1680

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

Communications & Power Industries Canada, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Mar 24, 2009 as substantially equivalent to K003438 (Cmt Medical Technologies, Ltd., 2001) after a 141-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it.

Decided: Mar 24, 2009
Review: 141 days
Class: Class II
Product code: MQB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003438 (2001). 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003438 Smart RadCmt Medical Technologies, Ltd. · 2001
This deviceK083224 Cpi Rad Vision, Model VZW2944XX-YYCommunications & Power Industries Canada, Inc. · 2009
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 16 descendants. See all descendants

Descendants cleared per year

2010high 4 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 16 · 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
−1	K003438	Smart Rad	Cmt Medical Technologies, Ltd.	2001	—
0 (this device)	K083224	Cpi Rad Vision, Model VZW2944XX-YY	Communications & Power Industries Canada, Inc.	2009	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	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 K083224, 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 MQB? 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 MQB device

#1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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
*	K003438	Smart Rad Summary page 2 …usion drawn from comparison: The CPI RAD VISION can be considered to be substantially equivalent to: CMT MEDICAL TECHNOLOGIES LTD. SMART RAD 510 (k) - K003438 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ,7<'…	Cmt Medical Technologies, Ltd.	2001	—

Also cleared against K003438: 4 other devices →

What descends from it? (16)

See all 16

2 later devices cite 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
K101042	Bladeview	Accogent, LLC	2010	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, K100449 (Minxray, Inc., 2010) has gone furthest, with 14 descendants of its own.
4 other devices also cite its predicate K003438.

How does its category compare?

All MQB devices

MQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MQB

8in 2025

2007high 32 (2014) · low 8 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQB

127in 2025

2007high 245 (2026) · low 15 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQB

1in 2025

2007high 36 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQB

141in 2025

2007high 267 (2012) · low 9 (2020)2025

MAUDE reports naming product code MQB, 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	13	22	15	25
2008	8	15	36	30
2009	15	57	19	34
2010	11	116	14	39
2011	24	102	10	101
2012	22	80	8	267
2013	21	105	6	159
2014	32	102	0	29
2015	21	81	0	21
2016	22	92	0	26
2017	31	30	1	20
2018	16	30	4	84
2019	22	30	1	45
2020	19	28	4	9
2021	21	48	1	26
2022	31	48	0	13
2023	10	30	0	51
2024	8	187	0	91
2025	8	127	1	141
2026	3	245	1	—

What is it indicated for?

The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems. The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both…

Read the full statement (166 words)

The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities.

The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION will not include the X-Ray system itself.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083224 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083224: Cpi Rad Vision, Model VZW2944XX-YY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083224

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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