510(k) · Cleared

Cleared

iQFlex Pro

K240009510(k) TraditionalCleared Jul 3, 2024183-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

First Source, Inc. · IZL System, X-Ray, Mobile

Cleared on Jul 3, 2024 as substantially equivalent to K182207 (Minxray, Inc., 2018) after a 183-day review. Its family tree reaches back 3 generations to 2004.

Decided: Jul 3, 2024
Review: 183 days
Class: Class II
Product code: IZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K040046 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
2 generations backK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
1 generation backK182207 TR90BHMinxray, Inc. · 2018
This deviceK240009 iQFlex ProFirst Source, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K040046	Minxray, Model HF120/60H Powerplus	Minxray, Inc.	2004	—
−2	K153059	HF1202H PowerPlus Portable X-ray Equipment	Minxray, Inc.	2016	—
−1	K182207	TR90BH	Minxray, Inc.	2018	—
0 (this device)	K240009	iQFlex Pro	First Source, Inc.	2024	—

FIG. 1 — Lineage of K240009, 2004–2024Source: 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
*	K182207	TR90BH Summary page 4 …VICE Name of Device: iQFlex Pro Regulation Name: Mobile X-ray system Regulation Number: 892.1720 Regulatory Class: II Product Code: IZL 3) PREDICATE DEVICE MinXray Inc. K182207 Name of Device: MinXray, MODEL TR90BH Regulation Name: Mobile X-ray system Regulation Number: 21 CFR 892.1720 Regulatory Class: I…	Minxray, Inc.	2018	—

Also cleared against K182207: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 20 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
None of the 3 ancestors has a recall.
8 other devices also cite its predicate K182207.

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. 2024, 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?

The iQFlex Pro Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest. - Not to be used on bariatric patients, unless imaging body extremities. Not for mammography use.

Not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K240009 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240009: iQFlex Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240009

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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