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 Oct 20, 2017 as substantially equivalent to K142037 (Hologic, Inc., 2014) after a 302-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Oct 20, 2017
- Review
- 302 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904519 (1991). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 6 generations between
- 3 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 2 generations backK120472 QuantraHologic, Inc. · 2012
- 1 generation backK142037 QuantraHologic, Inc. · 2014
- This deviceK163623 QuantraHologic, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 9 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 8 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 7 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 6 generations backK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- 5 generations backK073272 Workstationone Breast Imaging WorkstationThree Palm Software, LLC · 2007
- 4 generations backK082483 QuantraHologic, Inc. · 2008
- 3 generations backK102556 Volpara, Version 1.3Matakina Technology Limited · 2010
- 2 generations backK120472 QuantraHologic, Inc. · 2012
- 1 generation backK142037 QuantraHologic, Inc. · 2014
- This deviceK163623 QuantraHologic, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −9 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −8 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −7 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −6 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| −5 | K073272 | Workstationone Breast Imaging Workstation | Three Palm Software, LLC | 2007 | — |
| −4 | K082483 | Quantra | Hologic, Inc. | 2008 | — |
| −3 | K102556 | Volpara, Version 1.3 | Matakina Technology Limited | 2010 | — |
| −2 | K120472 | Quantra | Hologic, Inc. | 2012 | — |
| −1 | K142037 | Quantra | Hologic, Inc. | 2014 | — |
| 0 (this device) | K163623 | Quantra | Hologic, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K142037 | QuantraSummary page 4…LLZ Device Class: Class II Review Panel: Radiology Submitter/510(k) Holder: Hologic, Inc. Clearance: K142037 (cleared October 10, 2014) Device Description: Quantra is a software application used to produce assessments of breast compos… | 2014 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 22 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163623: Quantra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163623
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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