510(k) · Cleared

Recalled · Class II · 2024

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System

K221081510(k) TraditionalCleared Jun 13, 202262-day reviewClass II21 CFR 892.1720Recalls 1

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 Jun 13, 2022 as substantially equivalent to K040046 (Minxray, Inc., 2004) after a 62-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.

Decided: Jun 13, 2022
Review: 62 days
Class: Class II
Product code: IZL
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K040046 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
This deviceK221081 iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemFirst Source, Inc. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040046	Minxray, Model HF120/60H Powerplus	Minxray, Inc.	2004	—
0 (this device)	K221081	iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System	First Source, Inc.	2022	—

FIG. 1 — Lineage of K221081, 2004–2022Source: 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
*	K040046	Minxray, Model HF120/60H Powerplus Summary page 4 …ation Name: Mobile X-ray system Regulation Number: 892.1720 Regulatory Class: II Product Code: IZL III. PREDICATE DEVICE MinXray HF120/60HPowerPlus™, K040046 Name of Device: Min Xray, MODEL HF120/60H PowerPlusTM Regulation Name: Mobile X-ray system…	Minxray, Inc.	2004	—

Also cleared against K040046: 4 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2024	Class II	Z-2247-2024	Device Design	Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
4 other devices also cite its predicate K040046.

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. 2022, 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 M/iQFlex MD Mobile X-ray System is a medical device intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

This device is not intended for mammography.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K221081 · printed Nov 5, 2026

Cite this page

510(k) Report. “K221081: iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221081

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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