510(k) · Cleared
ClearedMammoScreen 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therapixel · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Nov 26, 2021 as substantially equivalent to K192854 (Therapixel, 2020) after a 191-day review. Its family tree reaches back 3 generations to 2018. 3 later devices descend from it.
- Decided
- Nov 26, 2021
- Review
- 191 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 2 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 1 generation backK192854 MammoScreenTherapixel · 2020
- This deviceK211541 MammoScreen 2.0Therapixel · 2021
- Descendant · cites it directly · 2 of its ownK240301 MammoScreen® (3)Therapixel · 2024
- Descendant · 2 generations on · 1 of its ownK243679 MammoScreen® (4)Therapixel · 2025
- Descendant · 3 generations on · 0 of its ownK260714 MammoScreen® (5)Therapixel · 2026
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 |
|---|---|---|---|---|---|
| −3 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −2 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −1 | K192854 | MammoScreen | Therapixel | 2020 | — |
| 0 (this device) | K211541 | MammoScreen 2.0 | Therapixel | 2021 | — |
| +1 | K240301 | MammoScreen® (3) | Therapixel | 2024 | — |
| +2 | K243679 | MammoScreen® (4) | Therapixel | 2025 | — |
| +3 | K260714 | MammoScreen® (5) | Therapixel | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 QDQ? 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 QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 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 |
|---|---|---|---|
| * | K192854 | MammoScreenSummary page 5…QDQ Submission type Traditional 510(k) 510(k) number: K211541 Predicate Device: The predicate device is MammoScreen, cleared under K192854. Device Description: MammoScreen 2.0 automatically processes the four views (one CC and one MLO per breast) of standard screenin… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240301 | MammoScreen® (3) | 2024 | 2 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240301 (Therapixel, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ since 2007.
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 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
MammoScreen® is intended for use as a concurrent reading aid for interpreting physicians, to
help identify findings on screening FFDM and DBT acquired with compatible mammography
systems and assess their level of suspicion. Output of the device includes marks placed on findings
on the mammogram and level of suspicion scores. The findings could be soft tissue lesions or
calcifications. The level of suspicion score is expressed at the finding level, for each breast and
overall for the mammogram. Patient management decisions should not be made solely on the basis
of analysis by MammoScreen®.
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/K211541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211541: MammoScreen 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211541
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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