510(k) · Cleared

Cleared

Q Lab Software

K021966510(k) TraditionalCleared Jul 2, 200215-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

Advanced Technology Laboratories, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jul 2, 2002 after a 15-day review. The FDA summary names its predicate without a number. 2 of the 659 devices in its family, counting itself, have a Class I recall. 658 later devices descend from it.

Decided: Jul 2, 2002
Review: 15 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

658 later devices descend from it, 14 citing it directly. 2 of the 659 devices in this family, counting this one, have a Class I recall.

This deviceK021966 Q Lab SoftwareAdvanced Technology Laboratories, Inc. · 2002
Descendant · cites it directly · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
Descendant · 2 generations on · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
Descendant · 3 generations on · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
Descendant · 2 generations on · 405 of its ownK121329 AixplorerSupersonic Imagine · 2012
Descendant · 3 generations on · 312 of its ownK132274 AixplorerSupersonic Imagine · 2013

Showing 5 of 658 descendants. See all descendants

Descendants cleared per year

2003high 61 (2025) · low 0 (2007)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System7 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System7 generations on · 2025

Most influential descendants

Showing 5 of 658 · See all

K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · cites it directly588descendants
K102041AixplorerSupersonic Imagine · 2010 · 2 generations on527descendants
K112255AixplorerSupersonic Imagine · 2012 · 3 generations on525descendants
K121329AixplorerSupersonic Imagine · 2012 · 2 generations on405descendants
K132274AixplorerSupersonic Imagine · 2013 · 3 generations on312descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021966	Q Lab Software	Advanced Technology Laboratories, Inc.	2002	—
+1	K093563	IU22 Ultrasound System and Transducers	Philips Ultrasound, Inc.	2010	2
+2	K102041	Aixplorer	Supersonic Imagine	2010	—
+3	K112255	Aixplorer	Supersonic Imagine	2012	—
+2	K121329	Aixplorer	Supersonic Imagine	2012	—
+3	K132274	Aixplorer	Supersonic Imagine	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2005	4	0
2006	2	0
2008	4	0
2010	2	0
2011	6	0
2012	12	0
2013	17	0
2014	16	0
2015	38	0
2016	44	0
2017	60	0
2018	51	0
2019	40	0
2020	58	0
2021	49	0
2022	48	0
2023	41	0
2024	56	0
2025	61	2
2026	46	0

FIG. 1 — Lineage of K021966, 2002–2026Source: 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.

2 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? (2)

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
*	—	MedLink Workstation Named without a submission number			—
*	—	Hewlett Packard Acoustic Densitometry Option Named without a submission number			—

What descends from it? (658)

See all 658

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

Number	Device	Applicant	Decided	Descendants
K093563	IU22 Ultrasound System and Transducers	Philips Ultrasound, Inc.	2010	588
K030223	Sonocalc	Sonometric Health, LLC	2003	146
K050846	B-Cad System, Version 1.0	The Medipattern Corporation	2005	123
K040686	M'ath STD	Intelligence IN Medical Technologies	2004	122
K121223	Qlab with FHN and VPQ Plug-in	Philips Ultrasound, Inc.	2012	98
K151663	RS80A Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	2015	96
K122536	Amcad-UT Detection Model 2.0	Lin & Associates, LLC	2013	69
K050376	Prowin	Medical Technologies International, Inc.	2005	22
K043360	Imt.Lab	Pie Medical	2005	22
K162574	AmCAD-US	Amcad Biomed Corporation	2017	0

Has anything in its family been recalled? (2 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

What does this lineage say?

Of its descendants, K093563 (Philips Ultrasound, Inc., 2010) has gone furthest, with 588 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?

The Q LAB Quantification software is a Windows 2000/Windows XP 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/K021966 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021966: Q Lab Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021966

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