510(k) · Cleared
ClearedClariSIGMAM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claripi, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 10, 2021 as substantially equivalent to K170540 (Densitas, Inc., 2018) after a 256-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Sep 10, 2021
- Review
- 256 days
- Class
- Class II
- Product code
- QIH
- 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 backK132742 M-VU Breast DensityVucomp, Inc. · 2013
- 1 generation backK170540 DM-DensityDensitas, Inc. · 2018
- This deviceK203785 ClariSIGMAMClaripi, Inc. · 2021
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 backK132742 M-VU Breast DensityVucomp, Inc. · 2013
- 1 generation backK170540 DM-DensityDensitas, Inc. · 2018
- This deviceK203785 ClariSIGMAMClaripi, Inc. · 2021
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 | K132742 | M-VU Breast Density | Vucomp, Inc. | 2013 | — |
| −1 | K170540 | DM-Density | Densitas, Inc. | 2018 | — |
| 0 (this device) | K203785 | ClariSIGMAM | Claripi, Inc. | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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.
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 3.5 years on median.
- 7 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K170540.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems.
ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.
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/K203785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203785: ClariSIGMAM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203785
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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