510(k) · Cleared
ClearedDenSeeMammo
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 Jun 26, 2018 as substantially equivalent to K152009 (Statlife, 2016) after a 218-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Jun 26, 2018
- Review
- 218 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K904519 (1991). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations between
- 3 generations backK082483 QuantraHologic, Inc. · 2008
- 2 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 1 generation backK152009 DENSEEMAMMO v1.0Statlife · 2016
- This deviceK173574 DenSeeMammoStatlife · 2018
Show all 9 generations
- Root · 9 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 8 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 7 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 6 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 5 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 4 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 3 generations backK082483 QuantraHologic, Inc. · 2008
- 2 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 1 generation backK152009 DENSEEMAMMO v1.0Statlife · 2016
- This deviceK173574 DenSeeMammoStatlife · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −8 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −7 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −6 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −5 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −4 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −3 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −2 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| −1 | K152009 | DENSEEMAMMO v1.0 | Statlife | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K152009 | DENSEEMAMMO v1.0Summary page 4…1 CFR § 892.2050 4 Identification of Predicate Device The modified software is substantially equivalent to DenSeeMammo Software version 1.0 cleared pursuant to K152009 cleared December 5th, 2017 |Page 1… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 21 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Full Field Digital Mammography systems. DenSeeMammo estimates BI-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure. DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not a diagnostic aid since the final…
Read the full statement (122 words)
DenSeeMammo is a software application intended for use with Full Field Digital Mammography systems.
DenSeeMammo estimates BI-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.
DenSeeMammo produces adjunctive information. It is not a diagnostic aid since 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 use 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 and Hologic Selenia Dimension systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173574: DenSeeMammo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173574
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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