510(k) · Cleared

Recalled · 2012

Practix Convenio

K042368510(k) AbbreviatedCleared Oct 4, 200434-day reviewClass II21 CFR 892.1720Recalls 4

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

Philips Medical Systems North America Co. · IZL System, X-Ray, Mobile

Cleared on Oct 4, 2004 as substantially equivalent to K894643 (Lorad Medical Systems, Inc., 1989) after a 34-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 4 times.

Decided: Oct 4, 2004
Review: 34 days
Class: Class II
Product code: IZL
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K894643 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK894643 RT-125 Rough Terrain Mobile X-Ray UnitLorad Medical Systems, Inc. · 1989
This deviceK042368 Practix ConvenioPhilips Medical Systems North America Co. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894643	RT-125 Rough Terrain Mobile X-Ray Unit	Lorad Medical Systems, Inc.	1989	—
0 (this device)	K042368	Practix Convenio	Philips Medical Systems North America Co.	2004	—

FIG. 1 — Lineage of K042368, 1989–2004Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K894643	RT-125 Rough Terrain Mobile X-Ray Unit Summary page 1 …eg. nr.: 21CFR 892.1720 3. Predicate device Trade name: RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (also known as PMX 2000) Manufacturer: Lorad 510(k) Number: K 894643 4. Description The Practix Convenio is a motor driven battery supplied mobile x-ray unit to be operated indoors only. The s…	Lorad Medical Systems, Inc.	1989	—

Also cleared against K894643: 1 other device →

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 2, 2012	Not classified	Z-1689-2012	Device Design	Unexpected Low-level X-ray pulse
Mar 23, 2007	Not classified	Z-0763-2007	Other	X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
Mar 23, 2007	Not classified	Z-0762-2007	Other	X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
Mar 23, 2007	Not classified	Z-0764-2007	Other	X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K894643.

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.

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 Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The PractixConvenio is intended to x-ray in rooms for medical use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042368 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042368: Practix Convenio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042368

Report an extraction error

Are you the manufacturer?

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