510(k) · Cleared
ClearedDENSEEMAMMO v1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Statlife · LLZ System, Image Processing, Radiological
Cleared on Dec 5, 2016 as substantially equivalent to K102556 (Matakina Technology Limited, 2010) after a 503-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- Dec 5, 2016
- Review
- 503 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904519 (1991). 20 ancestors in all. 1 later device descends from it, 1 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 deviceK152009 DENSEEMAMMO v1.0Statlife · 2016
- Descendant · cites it directly · 0 of its ownK173574 DenSeeMammoStatlife · 2018
Most influential descendants
Showing 1 of 1 · See all- K173574DenSeeMammoStatlife · 2018 · cites it directly0descendants
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) | K152009 | DENSEEMAMMO v1.0 | Statlife | 2016 | — |
| +1 | K173574 | DenSeeMammo | Statlife | 2018 | — |
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 | 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? (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 |
|---|---|---|---|
| * | K102556 | Volpara, Version 1.3Summary page 4…stem, Image Processing, Radiological: 21 CFR § 892.2050 4 Identification of Predicate Device The predicate device used for DenSeeMammo software is the following device: K102556 (October 7,2010) - VOLPARA Imaging Software (MATAKINA Technology Limited) 5 Device Description DenSeeMammo analyzes processed d… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173574 | DenSeeMammo | 2018 | 0 |
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 25 years and passes through 8 companies; a new generation was cleared every 3.6 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K173574 (Statlife, 2018) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K102556.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BI-RADS breast density value by analyzing processed digital 2D mammograms using a fully automated comparison procedure. DenSeeMammo provides a BI-RADS breast density 4th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final…
Read the full statement (118 words)
DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BI-RADS breast density value by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 4th Edition category to aid radiologists in the assessment of breast density.
DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician. DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers.
DenSeeMammo is compatible for images obtained from GE Senographe Essentials systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152009: DENSEEMAMMO v1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152009
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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