510(k) · Cleared

Cleared

Qlab Quantification Software

K040227510(k) TraditionalCleared Feb 17, 200415-day reviewClass II21 CFR 892.2050

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

Philips Ultrasound · LLZ System, Image Processing, Radiological

Cleared on Feb 17, 2004 after a 15-day review. The FDA summary names its predicate without a number. 6 of the 909 devices in its family, counting itself, have a Class I recall. 908 later devices descend from it.

Decided: Feb 17, 2004
Review: 15 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

908 later devices descend from it, 5 citing it directly. 6 of the 909 devices in this family, counting this one, have a Class I recall.

This deviceK040227 Qlab Quantification SoftwarePhilips Ultrasound · 2004
Descendant · cites it directly · 882 of its ownK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
Descendant · 2 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
Descendant · 3 generations on · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
Descendant · 4 generations on · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
Descendant · 3 generations on · 405 of its ownK121329 AixplorerSupersonic Imagine · 2012

Showing 5 of 908 descendants. See all descendants

Descendants cleared per year

2004high 78 (2025) · low 2 (2004)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System7 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System7 generations on · 2025
K162859 Allura Xper FD series and Allura Xper OR Table…8 generations on · 2016
K163715 Allura Xper R98 generations on · 2017

Most influential descendants

Showing 5 of 908 · See all

K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · cites it directly882descendants
K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 2 generations on588descendants
K102041AixplorerSupersonic Imagine · 2010 · 3 generations on527descendants
K112255AixplorerSupersonic Imagine · 2012 · 4 generations on525descendants
K121329AixplorerSupersonic Imagine · 2012 · 3 generations on405descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K040227	Qlab Quantification Software	Philips Ultrasound	2004	—
+1	K042540	Philips IU22 Ultrasound System	Philips Ultrasound, Inc.	2004	4
+2	K093563	IU22 Ultrasound System and Transducers	Philips Ultrasound, Inc.	2010	2
+3	K102041	Aixplorer	Supersonic Imagine	2010	—
+4	K112255	Aixplorer	Supersonic Imagine	2012	—
+3	K121329	Aixplorer	Supersonic Imagine	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	4	0
2006	5	0
2007	4	0
2008	14	0
2009	9	0
2010	17	0
2011	22	0
2012	23	0
2013	37	0
2014	38	0
2015	49	0
2016	58	1
2017	73	2
2018	65	0
2019	49	0
2020	74	1
2021	58	0
2022	59	0
2023	51	0
2024	62	0
2025	78	2
2026	57	0

FIG. 1 — Lineage of K040227, 2004–2026Source: 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.

6 devices in this family have a Class I recall. 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (3)

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	Recalls
*	—	Philips M2424 Diagnostic Ultrasound System Named without a submission number	—
*	—	TomTec Cardio-View Named without a submission number	—
*	—	HDI 5000 Named without a submission number	—

What descends from it? (908)

See all 908

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042540	Philips IU22 Ultrasound System	Philips Ultrasound, Inc.	2004	882
K050846	B-Cad System, Version 1.0	The Medipattern Corporation	2005	123
K130159	Qlab Quantification Software Heart Model	Philips Health Care	2013	92
K033266	Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager…	Medical Imaging Applications, LLC	2004	1
K103761	Visualize: Vascular	The Medipattern Corporation	2011	0

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

Of its descendants, K042540 (Philips Ultrasound, Inc., 2004) has gone furthest, with 882 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040227 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040227: Qlab Quantification Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040227

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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