510(k) · Cleared
ClearedQlab Quantification Software Heart Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Health Care · LLZ System, Image Processing, Radiological
Cleared on May 13, 2013 as substantially equivalent to K040227 (Philips Ultrasound, 2004) and 3 other predicates after a 110-day review. Its family tree reaches back 12 generations to 1995. 92 later devices descend from it.
- Decided
- May 13, 2013
- Review
- 110 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K935595 (1995). 80 ancestors in all, the oldest K891449 (1989). 92 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- This deviceK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · cites it directly · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- Descendant · 3 generations on · 44 of its ownK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- Descendant · 2 generations on · 43 of its ownK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
- Descendant · 4 generations on · 41 of its ownK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- This deviceK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −3 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −1 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +1 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +2 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| +3 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| +2 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017 | — |
| +4 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K040227 | Qlab Quantification SoftwareSummary page 1…hat the QLAB software with the Heart Model application is substantially equivalent to other commercially available products, including Philips QLAB Cardiac JDQ and 3DQA (K040227 & K(042540), Philips Brilliance CT (K(042293), and Siemens syngo US Workplace (K(09 1286). 4) Device Description The QLAB softw… | 2004 |
| * | K042540 | Philips IU22 Ultrasound SystemSummary page 1…software with the Heart Model application is substantially equivalent to other commercially available products, including Philips QLAB Cardiac JDQ and 3DQA (K040227 & K(042540), Philips Brilliance CT (K(042293), and Siemens syngo US Workplace (K(09 1286). 4) Device Description The QLAB software applica… | 2004 |
| * | K042293 | Brilliance CT, Private Practice CV Configuration, CT ScannerSummary page 2…ta acquired on Philips Healthcare ultrasound products. 6) Technological comparison to predicate devices QLAB Heart Model algorithm is reused from Philips Brilliance CT (K042293), but modified for ultrasound. It is similar to QLAB 3DQ/3DQA and the Brilliance CT Comprehensive Cardiac Analysis (CCA) in that… | 2004 |
| * | K091286 | Syngo US Workplace | 2009 |
What descends from it? (92)
See all 921 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132165 | Qlab Quantification Software | 2013 | 91 |
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 18 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 21 of the 80 ancestors have a recall of any class.
- Of its descendants, K132165 (Philips Ultrasound, Inc., 2013) has gone furthest, with 91 descendants of its own.
- 4 other devices also cite its predicate K040227.
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/K130159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130159: Qlab Quantification Software Heart Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130159
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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