510(k) · Cleared
ClearedVolpara Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volpara Health Technologies Limited · LLZ System, Image Processing, Radiological
Cleared on Jul 27, 2021 as substantially equivalent to K182310 (Volpara Health Technologies Limited, 2018) after a 91-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Jul 27, 2021
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- 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 deviceK211279 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2021
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 deviceK211279 Volpara Imaging SoftwareVolpara Health Technologies Limited · 2021
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) | 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 |
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 |
|---|---|---|---|
| * | K182310 | Volpara Imaging SoftwareSummary page 4…Predicate Devices: The modified software, Volpara Imaging Software (“Volpara”) 3.2 is substantially equivalent to the Volpara Imaging Software 1.5.6 cleared pursuant to K182310 (Volpara Health Technologies Limited), which serves as the primary predicate. Predicate Device Description: The Volpara Imaging… | 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 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 LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara Imaging Software 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 Imaging Software provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and…
Read the full statement (115 words)
Volpara Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara Imaging Software 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 Imaging Software provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and quality assurance metrics (i.e., dose and pressure) to aid healthcare professionals in the assessment of breast composition. Volpara Imaging Software is not a 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/K211279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211279: 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/K211279
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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