510(k) · Cleared
Cleareddensitas densityai
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Densitas, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 19, 2020 as substantially equivalent to K170540 (Densitas, Inc., 2018) after a 118-day review. Its family tree reaches back 10 generations to 1991. 5 later devices descend from it.
- Decided
- Feb 19, 2020
- Review
- 118 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904519 (1991). 22 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 6 generations between
- 3 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 2 generations backK132742 M-VU Breast DensityVucomp, Inc. · 2013
- 1 generation backK170540 DM-DensityDensitas, Inc. · 2018
- This deviceK192973 densitas densityaiDensitas, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK202013 WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK241561 MammoScreen BDTherapixel · 2024
- Descendant · cites it directly · 1 of its ownK222275 Saige-DensityDeepHealth, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK243685 MammoScreen BDTherapixel · 2025
- Descendant · 2 generations on · 0 of its ownK243705 Saige-Density (2.5.0)DeepHealth, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 9 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 8 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 7 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 6 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 5 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 4 generations backK082483 QuantraHologic, Inc. · 2008
- 3 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 2 generations backK132742 M-VU Breast DensityVucomp, Inc. · 2013
- 1 generation backK170540 DM-DensityDensitas, Inc. · 2018
- This deviceK192973 densitas densityaiDensitas, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. · 2020 · cites it directly2descendants
- K241561MammoScreen BDTherapixel · 2024 · 2 generations on1descendant
- K222275Saige-DensityDeepHealth, Inc. · 2022 · cites it directly1descendant
- K243685MammoScreen BDTherapixel · 2025 · 3 generations on0descendants
- K243705Saige-Density (2.5.0)DeepHealth, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −9 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −8 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −7 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −6 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −5 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −4 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −3 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| −2 | K132742 | M-VU Breast Density | Vucomp, Inc. | 2013 | — |
| −1 | K170540 | DM-Density | Densitas, Inc. | 2018 | — |
| 0 (this device) | K192973 | densitas densityai | Densitas, Inc. | 2020 | — |
| +1 | K202013 | WRDensity by Whiterabbit.ai | Whiterabbit.Ai, Inc. | 2020 | — |
| +2 | K241561 | MammoScreen BD | Therapixel | 2024 | — |
| +1 | K222275 | Saige-Density | DeepHealth, Inc. | 2022 | — |
| +3 | K243685 | MammoScreen BD | Therapixel | 2025 | — |
| +2 | K243705 | Saige-Density (2.5.0) | DeepHealth, Inc. | 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 |
|---|---|---|
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K170540 | DM-DensitySummary page 4…ssing, Radiological 21 CFR 892.2050 LLZ Device Classification: Class II Predicate Device(s): DM-Density™ 2.1.0b K170540 No reference devices were used in this submission Description of Device: Densitas densityai™ i… | 2018 |
What descends from it? (5)
2 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 29 years and passes through 9 companies; a new generation was cleared every 3.2 years on median.
- 7 of the 22 ancestors have a recall of any class.
- Of its descendants, K202013 (Whiterabbit.Ai, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K170540.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Densitas densityai™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densitas densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192973: densitas densityai.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192973
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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