510(k) · Cleared
ClearedQLAB Advanced 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 Jun 7, 2018 as substantially equivalent to K171314 (Philips Health Care, 2017) after a 24-day review. Its family tree reaches back 15 generations to 1995. 44 later devices descend from it.
- Decided
- Jun 7, 2018
- Review
- 24 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K935595 (1995). 85 ancestors in all, the oldest K891449 (1989). 44 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 2 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 1 generation backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- This deviceK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- Descendant · cites it directly · 41 of its ownK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- Descendant · 2 generations on · 18 of its ownK201012 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic…Philips Ultrasound, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 17 of its ownK211597 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic…Philips Medical Systems · 2021
- Descendant · 4 generations on · 16 of its ownK233788 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic…Philips Ultrasound, LLC · 2024 · Recalled
- Descendant · 5 generations on · 14 of its ownK240850 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series…Philips Ultrasound, LLC · 2024
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 6 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 5 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 4 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 2 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 1 generation backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- This deviceK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K191647QLAB Advanced Quantification SoftwarePhilips Health Care · 2019 · cites it directly41descendants
- K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc. · 2020 · 2 generations on18descendants
- K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems · 2021 · 3 generations on17descendants
- K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2024 · 4 generations on16descendants
- K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · 2024 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −6 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −5 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −4 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| −2 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| −1 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| 0 (this device) | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| +1 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| +2 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound… | Philips Ultrasound, Inc. | 2020 | 5 |
| +3 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic… | Philips Medical Systems | 2021 | — |
| +4 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic… | Philips Ultrasound, LLC | 2024 | 1 |
| +5 | K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic… | Philips Ultrasound, LLC | 2024 | — |
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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 13 | 0 |
| 2026 | 10 | 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? (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 | Decided |
|---|---|---|---|
| * | K171314 | QLAB Advanced Quantification SoftwareSummary page 4…Product code LLZ, Class II 3) Substantially Equivalent Devices Primary Predicate Device QLAB Modifications K171314 05/30/2017 Reference Devices QLAB Quantification Software with Heart Model K130159… | 2017 |
| † | K130159 | Qlab Quantification Software Heart Model | 2013 |
| † | K132165 | Qlab Quantification Software | 2013 |
What descends from it? (44)
See all 443 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)
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 23 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 22 of the 85 ancestors have a recall of any class.
- Of its descendants, K191647 (Philips Health Care, 2019) has gone furthest, with 41 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181264: QLAB Advanced 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/K181264
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