510(k) · Cleared
ClearedQuantra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 12, 2008 as substantially equivalent to K050196 (Sectra Imtec AB, 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 6 generations to 1991. 25 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904519 (1991). 18 ancestors in all. 25 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 4 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 3 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 2 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 1 generation backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- This deviceK082483 QuantraHologic, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- Descendant · cites it directly · 11 of its ownK132742 M-VU Breast DensityVucomp, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK152028 Volpara Imaging SoftwareMatakina Technologies Limited · 2015
- Descendant · 2 generations on · 7 of its ownK170540 DM-DensityDensitas, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK192973 densitas densityaiDensitas, Inc. · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K102556Volpara, Version 1.3Matakina Technology Limited · 2010 · cites it directly24descendants
- K132742M-VU Breast DensityVucomp, Inc. · 2013 · cites it directly11descendants
- K152028Volpara Imaging SoftwareMatakina Technologies Limited · 2015 · 2 generations on8descendants
- K170540DM-DensityDensitas, Inc. · 2018 · 2 generations on7descendants
- K192973densitas densityaiDensitas, Inc. · 2020 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −5 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −4 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −3 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −2 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −1 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| 0 (this device) | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| +1 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| +1 | K132742 | M-VU Breast Density | Vucomp, Inc. | 2013 | — |
| +2 | K152028 | Volpara Imaging Software | Matakina Technologies Limited | 2015 | — |
| +2 | K170540 | DM-Density | Densitas, Inc. | 2018 | — |
| +3 | K192973 | densitas densityai | Densitas, Inc. | 2020 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K050196 | Sectra IDS5 WorkstationSummary page 1…90-LLZ Predicate Devices: The predicate devices for Quantra software are certain software functions contained in the following devices: K050196, Feb 24, 2005 Sectra IDS5 Workstation [Sectra Imtec AB] K073272, Dec 11, 2007 WorkstationOne TM Breast Imaging W… | 2005 |
| * | K073272 | Workstationone Breast Imaging WorkstationSummary page 1…ftware are certain software functions contained in the following devices: K050196, Feb 24, 2005 Sectra IDS5 Workstation [Sectra Imtec AB] K073272, Dec 11, 2007 WorkstationOne TM Breast Imaging Workstation [Three Palm Software, LLC] Device Description: Quantra… | 2007 |
What descends from it? (25)
See all 253 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 17 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 7 of the 18 ancestors have a recall of any class.
- Of its descendants, K102556 (Matakina Technology Limited, 2010) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K050196.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
QuantraTM is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.
Quantra is a software application which runs on the Hologic Cenova DICOM server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082483: Quantra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082483
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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