510(k) · Cleared
Recalled · Class II · 2014Qlab Quantification Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 9, 2013 as substantially equivalent to K042540 (Philips Ultrasound, Inc., 2004) and 3 other predicates after a 28-day review. Its family tree reaches back 13 generations to 1995. 91 later devices descend from it. It has been recalled once.
- Decided
- Aug 9, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 13 generations to K935595 (1995). 83 ancestors in all, the oldest K891449 (1989). 91 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- This deviceK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013
- Descendant · cites it directly · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- Descendant · 2 generations on · 44 of its ownK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- Descendant · cites it directly · 43 of its ownK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
- Descendant · 3 generations on · 41 of its ownK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- Descendant · 2 generations on · 28 of its ownK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- This deviceK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · cites it directly45descendants
- K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018 · 2 generations on44descendants
- K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017 · cites it directly43descendants
- K191647QLAB Advanced Quantification SoftwarePhilips Health Care · 2019 · 3 generations on41descendants
- K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −4 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| 0 (this device) | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | — |
| +1 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| +2 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| +1 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017 | — |
| +3 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| +2 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 12 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 0 |
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 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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 1…Devices Philips Ultrasound believes that the modified QLAB a2DQ, aCMQ, MVN, and Heart Model Q-Apps are substantially equivalent to the previously cleared iU22 with 2DQ (K042540), QLAB with MVQ (K070792), QLAB CMQ (K120525), and QLAB Heart Model (130159). 4) Device Description QLAB Quantification softwar… | 2004 |
| * | K070792 | Qlab QuantificationSummary page 1…nd believes that the modified QLAB a2DQ, aCMQ, MVN, and Heart Model Q-Apps are substantially equivalent to the previously cleared iU22 with 2DQ (K042540), QLAB with MVQ (K070792), QLAB CMQ (K120525), and QLAB Heart Model (130159). 4) Device Description QLAB Quantification software is available either as… | 2007 |
| * | K120525 | Qlab Quantification SoftwareSummary page 1…modified QLAB a2DQ, aCMQ, MVN, and Heart Model Q-Apps are substantially equivalent to the previously cleared iU22 with 2DQ (K042540), QLAB with MVQ (K070792), QLAB CMQ (K120525), and QLAB Heart Model (130159). 4) Device Description QLAB Quantification software is available either as a stand-alone produc… | 2012 |
| * | K130159 | Qlab Quantification Software Heart ModelSummary page 1…and Heart Model Q-Apps are substantially equivalent to the previously cleared iU22 with 2DQ (K042540), QLAB with MVQ (K070792), QLAB CMQ (K120525), and QLAB Heart Model (130159). 4) Device Description QLAB Quantification software is available either as a stand-alone product that can function on a standa… | 2013 |
What descends from it? (91)
See all 913 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2014 | Class II | Z-0815-2015 | Software design | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 21 of the 83 ancestors have a recall of any class.
- Of its descendants, K171314 (Philips Health Care, 2017) has gone furthest, with 45 descendants of its own.
- 11 other devices also cite its predicate K042540.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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 Healthcare ultrasound products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132165: Qlab Quantification Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132165
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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