510(k) · Cleared
ClearedVolpara Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matakina Technologies Limited · LLZ System, Image Processing, Radiological
Cleared on Oct 26, 2015 as substantially equivalent to K102556 (Matakina Technology Limited, 2010) after a 96-day review. Its family tree reaches back 8 generations to 1991. 8 later devices descend from it.
- Decided
- Oct 26, 2015
- Review
- 96 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904519 (1991). 20 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 7 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 6 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 5 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 4 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 3 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 2 generations backK082483 QuantraHologic, Inc. · 2008
- 1 generation backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- This deviceK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- Descendant · cites it directly · 3 of its ownK153427 Volpara Imaging SoftwareMatakina Technology, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK182310 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018
- Descendant · cites it directly · 2 of its ownK180125 PowerLook Density Assessment SoftwareIcad, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK232096 Transpara Density 1.0.0Screenpoint Medical B.V. · 2023
- Descendant · 3 generations on · 0 of its ownK211279 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153427Volpara Imaging SoftwareMatakina Technology, Ltd. · 2016 · cites it directly3descendants
- K182310Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018 · 2 generations on2descendants
- K180125PowerLook Density Assessment SoftwareIcad, Inc. · 2018 · cites it directly2descendants
- K232096Transpara Density 1.0.0Screenpoint Medical B.V. · 2023 · 3 generations on0descendants
- K211279Volpara Imaging SoftwareVolpara Health Technologies Limited · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −7 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −6 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −5 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −4 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −3 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −2 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −1 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| 0 (this device) | K152028 | Volpara Imaging Software | Matakina Technologies Limited | 2015 | — |
| +1 | K153427 | Volpara Imaging Software | Matakina Technology, Ltd. | 2016 | — |
| +2 | K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | 2018 | — |
| +1 | K180125 | PowerLook Density Assessment Software | Icad, Inc. | 2018 | — |
| +3 | K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | 2023 | — |
| +3 | K211279 | Volpara Imaging Software | Volpara Health Technologies Limited | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2021 | 3 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K102556 | Volpara, Version 1.3Summary page 4…892.2050; LLZ Legally Marketed Predicate Devices: The modified software is substantially equivalent to the Volpara Imaging Software (“Volpara”) 1.3 cleared pursuant to K102556 (Matakina Technology Limited) cleared October 7th, 2010. Predicate Device Description: Strictly Confidential… | 2010 |
What descends from it? (8)
3 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 24 years and passes through 8 companies; a new generation was cleared every 3.6 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K153427 (Matakina Technology, Ltd., 2016) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K102556.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid.
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/K152028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152028: Volpara Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152028
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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