510(k) · Cleared
ClearedPowerLook Density Assessment Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icad, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 5, 2018 as substantially equivalent to K132742 (Vucomp, Inc., 2013) and 1 other predicate after a 79-day review. Its family tree reaches back 9 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 5, 2018
- Review
- 79 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K904519 (1991). 22 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK132742 M-VU Breast DensityVucomp, Inc. · 2013
- This deviceK180125 PowerLook Density Assessment SoftwareIcad, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK211506 PowerLook Density Assessment V4.0Icad, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK201411 Visage Breast DensityVisage Imaging GmbH · 2021
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 backK132742 M-VU Breast DensityVucomp, Inc. · 2013
- This deviceK180125 PowerLook Density Assessment SoftwareIcad, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView 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 | K132742 | M-VU Breast Density | Vucomp, Inc. | 2013 | — |
| 0 (this device) | K180125 | PowerLook Density Assessment Software | Icad, Inc. | 2018 | — |
| +1 | K211506 | PowerLook Density Assessment V4.0 | Icad, Inc. | 2021 | — |
| +1 | K201411 | Visage Breast Density | Visage Imaging GmbH | 2021 | — |
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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K132742 | M-VU Breast DensitySummary page 5…eted predicate devices. Device Name Manufacturer 510(k) Reference # Concurrence Date iReveal V1.0* iCAD Inc. K132742 December 3, 2013 Volpara Imaging October 26, 2015… | 2013 |
| * | K152028 | Volpara Imaging SoftwareSummary page 5…December 3, 2013 Volpara Imaging October 26, 2015 Matakina Technology K152028 Software * Cleared under the M-Vu Brand Name (VuCOMP Inc.) iCAD Acquired VuCOMP. Device Description The PowerLo… | 2015 |
What descends from it? (2)
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 27 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, K211506 (Icad, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132742.
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?
PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180125 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180125: PowerLook Density Assessment Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180125
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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