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 Jun 22, 2012 as substantially equivalent to K082483 (Hologic, Inc., 2008) and 2 other predicates after a 127-day review. Its family tree reaches back 8 generations to 1991. 3 later devices descend from it.
- Decided
- Jun 22, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K904519 (1991). 20 ancestors in all. 3 later devices descend from it, 2 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 deviceK120472 QuantraHologic, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK142037 QuantraHologic, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK163623 QuantraHologic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK130704 Microdose SIPhilips Digital Mammography Sweden AB · 2013
Most influential descendants
Showing 3 of 3 · See allView 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) | K120472 | Quantra | Hologic, Inc. | 2012 | — |
| +1 | K142037 | Quantra | Hologic, Inc. | 2014 | — |
| +2 | K163623 | Quantra | Hologic, Inc. | 2017 | — |
| +1 | K130704 | Microdose SI | Philips Digital Mammography Sweden AB | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K082483 | QuantraSummary page 1…90-LLZ Predicate Devic tes: The .predicate devices for Quantra software are certain software fuinctions contained in the following devices: 1(082483,:Septemiber 12i 2008 Quanira (Volumetric Assessment) [HologicIne.] K050196, February 24,2005 SectraIDS5 Workstation [Sect… | 2008 |
| * | K050196 | Sectra IDS5 WorkstationSummary page 1…tra software are certain software fuinctions contained in the following devices: 1(082483,:Septemiber 12i 2008 Quanira (Volumetric Assessment) [HologicIne.] K050196, February 24,2005 SectraIDS5 Workstation [Sectra Initec AB] KI102556, October 7, 2010 Volpara Imaging Software [Matak… | 2005 |
| * | K102556 | Volpara, Version 1.3Summary page 1…vices: 1(082483,:Septemiber 12i 2008 Quanira (Volumetric Assessment) [HologicIne.] K050196, February 24,2005 SectraIDS5 Workstation [Sectra Initec AB] KI102556, October 7, 2010 Volpara Imaging Software [Matakina Technology Limited] ‘Device beséripfiofitf ‘..Quantra… | 2010 |
What descends from it? (3)
2 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 21 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K142037 (Hologic, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K082483.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Quantra Tm is a software application intended for use with images acquired using digital breast X-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates; and area breast density as a ratio of fibroglandular tissue area and total breast area estimates. It segregates breast density into BL1-RADS-Iike breast composition categories, which may be useful in the reporting of consistent…
Read the full statement (115 words)
Quantra Tm is a software application intended for use with images acquired using digital breast X-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates; and area breast density as a ratio of fibroglandular tissue area and total breast area estimates. It segregates breast density into BL1-RADS-Iike breast composition categories, which may be useful in the reporting of consistent breast composition values as mandated by certain state regulations. Quantra provides these numerical values for each image, breast, and subject, to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra runs on a Windows platform.
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/K120472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120472: Quantra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120472
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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