510(k) · Cleared
ClearedVolpara Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matakina Technology, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jan 7, 2016 as substantially equivalent to K152028 (Matakina Technologies Limited, 2015) and 1 other predicate after a 43-day review. Its family tree reaches back 9 generations to 1991. 3 later devices descend from it.
- Decided
- Jan 7, 2016
- Review
- 43 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K904519 (1991). 21 ancestors in all. 3 later devices descend from it, 1 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 backK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- This deviceK153427 Volpara Imaging SoftwareMatakina Technology, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK182310 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018
- Descendant · 2 generations on · 0 of its ownK232096 Transpara Density 1.0.0Screenpoint Medical B.V. · 2023
- Descendant · 2 generations on · 0 of its ownK211279 Volpara Imaging SoftwareVolpara Health Technologies Limited · 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 backK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- This deviceK153427 Volpara Imaging SoftwareMatakina Technology, Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K182310Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018 · cites it directly2descendants
- K232096Transpara Density 1.0.0Screenpoint Medical B.V. · 2023 · 2 generations on0descendants
- K211279Volpara Imaging SoftwareVolpara Health Technologies Limited · 2021 · 2 generations on0descendants
View 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 | K152028 | Volpara Imaging Software | Matakina Technologies Limited | 2015 | — |
| 0 (this device) | K153427 | Volpara Imaging Software | Matakina Technology, Ltd. | 2016 | — |
| +1 | K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | 2018 | — |
| +2 | K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 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? (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 |
|---|---|---|---|
| * | K152028 | Volpara Imaging SoftwareSummary page 4…redicate Devices: The modified software, Volpara Imaging Software (“Volpara”) 1.5.2 is substantially equivalent to the Volpara Imaging Software 1.5.1 cleared pursuant to K152028 (Matakina Technology Limited) on October 26th, 2015, which serves as the primary predicate, as well as K102556 cleared on 7th Oct… | 2015 |
| * | K102556 | Volpara, Version 1.3Summary page 4…to the Volpara Imaging Software 1.5.1 cleared pursuant to K152028 (Matakina Technology Limited) on October 26th, 2015, which serves as the primary predicate, as well as K102556 cleared on 7th October, 2010. Predicate Device Description: Volpara Imaging Software 1.5.1 generated and validated density maps… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182310 | Volpara Imaging Software | 2018 | 2 |
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 25 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K182310 (Volpara Health Technologies Limited, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K152028.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 and quantifies 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 is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA qualified interpreting physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153427: 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/K153427
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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