510(k) · Cleared
ClearedM-VU Breast Density
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vucomp, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 3, 2013 as substantially equivalent to K082483 (Hologic, Inc., 2008) and 1 other predicate after a 91-day review. Its family tree reaches back 8 generations to 1991. 11 later devices descend from it.
- Decided
- Dec 3, 2013
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K904519 (1991). 20 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 7 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 6 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 5 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 4 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 3 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 2 generations backK082483 QuantraHologic, Inc. · 2008
- 1 generation backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- This deviceK132742 M-VU Breast DensityVucomp, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK170540 DM-DensityDensitas, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK192973 densitas densityaiDensitas, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK202013 WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK180125 PowerLook Density Assessment SoftwareIcad, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK241561 MammoScreen BDTherapixel · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170540DM-DensityDensitas, Inc. · 2018 · cites it directly7descendants
- K192973densitas densityaiDensitas, Inc. · 2020 · 2 generations on5descendants
- K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. · 2020 · 3 generations on2descendants
- K180125PowerLook Density Assessment SoftwareIcad, Inc. · 2018 · cites it directly2descendants
- K241561MammoScreen BDTherapixel · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −7 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −6 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −5 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −4 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −3 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −2 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −1 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| 0 (this device) | K132742 | M-VU Breast Density | Vucomp, Inc. | 2013 | — |
| +1 | K170540 | DM-Density | Densitas, Inc. | 2018 | — |
| +2 | K192973 | densitas densityai | Densitas, Inc. | 2020 | — |
| +3 | K202013 | WRDensity by Whiterabbit.ai | Whiterabbit.Ai, Inc. | 2020 | — |
| +1 | K180125 | PowerLook Density Assessment Software | Icad, Inc. | 2018 | — |
| +4 | K241561 | MammoScreen BD | Therapixel | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K082483 | QuantraSummary page 1…System. Image Processing, Radiological; 21 CFR 892.2050; LLZ Device Classification: Class 11 Predicate Device(s): Quantra, by Hologic Inc., K082483 Volpara, Matakina Technology Limited. K 102556 Description of Device: M-Vu Breast Density automatically a… | 2008 |
| * | K102556 | Volpara, Version 1.3Summary page 1…R 892.2050; LLZ Device Classification: Class 11 Predicate Device(s): Quantra, by Hologic Inc., K082483 Volpara, Matakina Technology Limited. K 102556 Description of Device: M-Vu Breast Density automatically analyzes "for processing" digital mammograms and calculates the dense ti… | 2010 |
What descends from it? (11)
See all 112 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 22 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K170540 (Densitas, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K082483.
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?
M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132742: M-VU Breast Density.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132742
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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