510(k) · Cleared
ClearedVisage Breast Density
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visage Imaging GmbH · QIH Automated Radiological Image Processing Software
Cleared on Jan 29, 2021 as substantially equivalent to K180125 (Icad, Inc., 2018) after a 246-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Jan 29, 2021
- Review
- 246 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904519 (1991). 23 ancestors in all. No later device cites it as a predicate yet.
- 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 backK180125 PowerLook Density Assessment SoftwareIcad, Inc. · 2018
- This deviceK201411 Visage Breast DensityVisage Imaging GmbH · 2021
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 backK180125 PowerLook Density Assessment SoftwareIcad, Inc. · 2018
- This deviceK201411 Visage Breast DensityVisage Imaging GmbH · 2021
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 | K180125 | PowerLook Density Assessment Software | Icad, Inc. | 2018 | — |
| 0 (this device) | 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 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K180125 | PowerLook Density Assessment SoftwareSummary page 4…ss Class II Review Panel Radiology Submitter iCAD, Inc. 510(k) Number K180125 Clearance April 5, 2018 ___________________________________________________________________________… | 2018 |
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 30 years and passes through 10 companies; a new generation was cleared every 3.2 years on median.
- 7 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K180125.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Visage Breast Density assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. Visage Breast Density produces adjunctive information. It is not a diagnostic aid.
Visage Breast Density is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images.
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/K201411 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201411: Visage Breast Density.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201411
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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