510(k) · Cleared
ClearedQlab Quantification
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 Apr 6, 2007 after a 15-day review. The FDA summary names its predicate without a number. 202 later devices descend from it.
- Decided
- Apr 6, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
202 later devices descend from it, 6 citing it directly.
- This deviceK070792 Qlab QuantificationPhilips Ultrasound, Inc. · 2007
- Descendant · cites it directly · 98 of its ownK121223 Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012
- Descendant · cites it directly · 92 of its ownK120525 Qlab Quantification SoftwarePhilips Healthcare Group · 2012
- Descendant · cites it directly · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 3 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc. · 2012 · cites it directly98descendants
- K120525Qlab Quantification SoftwarePhilips Healthcare Group · 2012 · cites it directly92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · cites it directly91descendants
- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 2 generations on64descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070792 | Qlab Quantification | Philips Ultrasound, Inc. | 2007 | — |
| +1 | K121223 | Qlab with FHN and VPQ Plug-in | Philips Ultrasound, Inc. | 2012 | — |
| +1 | K120525 | Qlab Quantification Software | Philips Healthcare Group | 2012 | — |
| +1 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +2 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 17 | 0 |
| 2019 | 15 | 0 |
| 2020 | 26 | 0 |
| 2021 | 18 | 0 |
| 2022 | 24 | 0 |
| 2023 | 17 | 0 |
| 2024 | 22 | 0 |
| 2025 | 23 | 0 |
| 2026 | 20 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | TomTec 4D MV-Assessment software Named without a submission number | |
| * | — | GE Healthcare AFI software Named without a submission number | |
| † | K042540 | Philips IU22 Ultrasound System | 2004 |
What descends from it? (202)
See all 2026 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?
- Of its descendants, K121223 (Philips Ultrasound, Inc., 2012) has gone furthest, with 98 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. 2007, 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 Medical Systems ultrasound products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070792 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070792: Qlab Quantification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070792
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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