510(k) · Cleared
ClearedTranspara Density 1.0.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Screenpoint Medical B.V. · QIH Automated Radiological Image Processing Software
Cleared on Dec 11, 2023 as substantially equivalent to K182310 (Volpara Health Technologies Limited, 2018) after a 151-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Dec 11, 2023
- Review
- 151 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K904519 (1991). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 7 generations between
- 3 generations backK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- 2 generations backK153427 Volpara Imaging SoftwareMatakina Technology, Ltd. · 2016
- 1 generation backK182310 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018
- This deviceK232096 Transpara Density 1.0.0Screenpoint Medical B.V. · 2023
Show all 11 generations
- Root · 11 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 10 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 9 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 8 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 7 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 6 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 5 generations backK082483 QuantraHologic, Inc. · 2008
- 4 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 3 generations backK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- 2 generations backK153427 Volpara Imaging SoftwareMatakina Technology, Ltd. · 2016
- 1 generation backK182310 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018
- This deviceK232096 Transpara Density 1.0.0Screenpoint Medical B.V. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −10 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −9 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −8 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −7 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −6 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −5 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −4 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| −3 | K152028 | Volpara Imaging Software | Matakina Technologies Limited | 2015 | — |
| −2 | K153427 | Volpara Imaging Software | Matakina Technology, Ltd. | 2016 | — |
| −1 | K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | 2018 | — |
| 0 (this device) | K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | 2023 | — |
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 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 23.5 · 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 |
|---|---|---|---|
| * | K182310 | Volpara Imaging SoftwareSummary page 5…892.2050 Panel Radiology Device class II Product code LLZ Clearance number K182310 4. Device description Transpara Density is a software module that uses artificial intelligence techniques to assess breas… | 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 32 years and passes through 11 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K182310.
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. 2023, 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?
Transpara Density is a software application intended for use with data from compatible digital mammography and digital breast tomosynthesis systems. Transpara Density utilises deep learning artificial intelligence algorithms to automatically determine volumetric breast density (VBD), breast volume, and an ACR BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. It is not a diagnostic aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232096: Transpara Density 1.0.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232096
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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