510(k) · Cleared
ClearedQlab with FHN and VPQ Plug-in
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 May 15, 2012 as substantially equivalent to K070792 (Philips Ultrasound, Inc., 2007) and 3 other predicates after a 22-day review. Its family tree reaches back 7 generations to 2000. 98 later devices descend from it.
- Decided
- May 15, 2012
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K003525 (2000). 11 ancestors in all. 98 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 6 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- 5 generations backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- 4 generations backK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · Recalled
- 3 generations backK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
- 2 generations backK112213 Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · Recalled
- 1 generation backK113758 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- This deviceK121223 Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012
- Descendant · cites it directly · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 2 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · cites it directly · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 2 generations on · 42 of its ownK171070 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 2 generations on · 39 of its ownK173204 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · cites it directly64descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on58descendants
- K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · cites it directly50descendants
- K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on42descendants
- K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 2 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −6 | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| −5 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| −4 | K061682 | GE Voluson E8 Ultrasound System | General Electric Co. | 2006 | 3 |
| −3 | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/… | GE Healthcare | 2011 | — |
| −2 | K112213 | Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System | GE Healthcare | 2011 | 1 |
| −1 | K113758 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| 0 (this device) | K121223 | Qlab with FHN and VPQ Plug-in | Philips Ultrasound, Inc. | 2012 | — |
| +1 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +2 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +1 | K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 10 | 0 |
| 2022 | 10 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 9 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K070792 | Qlab QuantificationSummary page 1…he QLAB software with " Fetal Heart Navigator (FHN) Plug-in is substantially equivalent to other commercially available products, including Philips QLAB MVQ (K070792) and GE's VoIlson Expert 8 VCAD (KI 113758). " Vascular Plaque Quantification (VPQ) plug-in is Substantially equivale… | 2007 |
| * | K113758 | Voluson E6/E8/E8EXPERT/E10Summary page 1…HN) Plug-in is substantially equivalent to other commercially available products, including Philips QLAB MVQ (K070792) and GE's VoIlson Expert 8 VCAD (KI 113758). " Vascular Plaque Quantification (VPQ) plug-in is Substantially equivalent to other commercially available products… | 2012 |
| * | K021966 | Q Lab SoftwareSummary page 1…(KI 113758). " Vascular Plaque Quantification (VPQ) plug-in is Substantially equivalent to other commercially available products, including Philips QLAB ROI (K02 1966) and [MT's M'Ath® Std (K040686). 4) Device Description The QLAB software application is available either as a stand-alo… | 2002 |
| * | K040686 | M'ath STDSummary page 1…ification (VPQ) plug-in is Substantially equivalent to other commercially available products, including Philips QLAB ROI (K02 1966) and [MT's M'Ath® Std (K040686). 4) Device Description The QLAB software application is available either as a stand-alone product that can fun~ction on a stan… | 2004 |
What descends from it? (98)
See all 983 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 12 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K162094 (Samsung Medison Co., Ltd., 2016) has gone furthest, with 64 descendants of its own.
- 5 other devices also cite its predicate K070792.
How does its category compare?
All LLZ devicesLLZ 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
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/K121223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121223: Qlab with FHN and VPQ Plug-in.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121223
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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