510(k) Report

510(k) · Cleared

Cleared

Qlab Quantification Software

K120525510(k) SpecialCleared Mar 9, 201216-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 Healthcare Group · LLZ System, Image Processing, Radiological

Cleared on Mar 9, 2012 as substantially equivalent to K070792 (Philips Ultrasound, Inc., 2007) and 1 other predicate after a 16-day review. Its family tree reaches back 4 generations to 1995. 92 later devices descend from it.

Decided
Mar 9, 2012
Review
16 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K934139 (1995). 9 ancestors in all. 92 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestors2013: 1 descendant cleared2017: 3 descendants cleared2018: 3 descendants cleared2021: 7 descendants cleared2020: 11 descendants cleared2019: 5 descendants cleared2025: 17 descendants cleared2026: 14 descendants cleared2022: 11 descendants cleared2024: 12 descendants cleared2023: 8 descendants clearedK934139 · Tomtec Echo-View · Tomtec Tomographic Technologies GmbH · 1995K993398 · Echo View, Easy View, Omni View · Tomtec Imaging Systems GmbH · 1999K022824 · Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X · Tomtec Imaging Systems GmbH · 2002K042540 · Philips IU22 Ultrasound System · Philips Ultrasound, Inc. · 2004 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 13 descendants5 generations forward: 19 descendants6 generations forward: 14 descendants7 generations forward: 9 descendants8 generations forward: 6 descendants9 generations forward: 9 descendants10 generations forward: 6 descendants11 generations forward: 2 descendants12 generations forward: 1 descendant K042540 · Philips IU22 Ultrasound System · Philips Ultrasound, Inc. · 2004 · recalledK022824 · Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X · Tomtec Imaging Systems GmbH · 2002K993398 · Echo View, Easy View, Omni View · Tomtec Imaging Systems GmbH · 1999K934139 · Tomtec Echo-View · Tomtec Tomographic Technologies GmbH · 19950+5+10
  1. Root · 4 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
  2. 3 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
  3. 2 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
  4. 1 generation backK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
  5. This deviceK120525 Qlab Quantification SoftwarePhilips Healthcare Group · 2012
  6. Descendant · cites it directly · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
  7. Descendant · 2 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
  8. Descendant · 3 generations on · 44 of its ownK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
  9. Descendant · 2 generations on · 43 of its ownK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
  10. Descendant · 4 generations on · 41 of its ownK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2013: 12017: 32018: 32019: 52020: 112021: 72022: 112023: 82024: 122025: 172026: 14
2013high 17 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 92 · See all
  • K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · cites it directly91descendants
  • K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · 2 generations on45descendants
  • K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018 · 3 generations on44descendants
  • K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017 · 2 generations on43descendants
  • K191647QLAB Advanced Quantification SoftwarePhilips Health Care · 2019 · 4 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K934139Tomtec Echo-ViewTomtec Tomographic Technologies GmbH1995—
−3K993398Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH1999—
−2K022824Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X…Tomtec Imaging Systems GmbH2002—
−1K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc.20044
0 (this device)K120525Qlab Quantification SoftwarePhilips Healthcare Group2012—
+1K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.20131
+2K171314QLAB Advanced Quantification SoftwarePhilips Health Care2017—
+3K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.2018—
+2K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare2017—
+4K191647QLAB Advanced Quantification SoftwarePhilips Health Care2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200210
200410
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201730
201830
201950
2020110
202170
2022110
202380
2024120
2025170
2026140
FIG. 1 — Lineage of K120525, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LLZ? 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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K070792Qlab Quantification
Summary page 1
…alent Devices Philips Ultrasound believes that the modified QLAB CMQ Plug-in is substantially equivalent to the previously cleared QLAB TMQ Plug-in marketed pursuant to K070792, and K042540. Originally marketed as TMQ, the QLAB CMQ Plug-in was documented in a letter to file as described in QLAB 5 10O(k) K…
Philips Ultrasound, Inc.2007—
*K042540Philips IU22 Ultrasound System
Summary page 1
…Philips Ultrasound believes that the modified QLAB CMQ Plug-in is substantially equivalent to the previously cleared QLAB TMQ Plug-in marketed pursuant to K070792, and K042540. Originally marketed as TMQ, the QLAB CMQ Plug-in was documented in a letter to file as described in QLAB 5 10O(k) Ki 10414. 4)…
Philips Ultrasound, Inc.20044

Also cleared against K070792: 5 other devices →

What descends from it? (92)

See all 92

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.201391

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 17 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K132165 (Philips Ultrasound, Inc., 2013) has gone furthest, with 91 descendants of its own.
  • 5 other devices also cite its predicate K070792.

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. 2012, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
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

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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.

Also cleared against K070792

5 other devices cite the same predicate.

  • K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
  • K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
  • K130779Lvivo EF SystemDiacardio, Ltd. · 2013
  • K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 20131 recall
  • K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K120525 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120525: 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/K120525

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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