510(k) · Cleared
ClearedMammoScreen® (4)
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 Jul 3, 2025 as substantially equivalent to K240301 (Therapixel, 2024) after a 216-day review. Its family tree reaches back 5 generations to 2018. 1 later device descends from it.
- Decided
- Jul 3, 2025
- Review
- 216 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN180005 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 4 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 3 generations backK192854 MammoScreenTherapixel · 2020
- 2 generations backK211541 MammoScreen 2.0Therapixel · 2021
- 1 generation backK240301 MammoScreen® (3)Therapixel · 2024
- This deviceK243679 MammoScreen® (4)Therapixel · 2025
- Descendant · cites it directly · 0 of its ownK260714 MammoScreen® (5)Therapixel · 2026
Most influential descendants
Showing 1 of 1 · See all- K260714MammoScreen® (5)Therapixel · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −4 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −3 | K192854 | MammoScreen | Therapixel | 2020 | — |
| −2 | K211541 | MammoScreen 2.0 | Therapixel | 2021 | — |
| −1 | K240301 | MammoScreen® (3) | Therapixel | 2024 | — |
| 0 (this device) | K243679 | MammoScreen® (4) | Therapixel | 2025 | — |
| +1 | K260714 | MammoScreen® (5) | Therapixel | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K240301 | MammoScreen® (3)Summary page 6…Page 1 of 8 510(k) submission MammoScreen 4 Predicate Device: The predicate device is MammoScreen 3, cleared under K240301 (Product code QDQ). Device Description: MammoScreen 4 is a concurrent reading medical software device using artificial intellige… | 2024 |
| † | K192854 | MammoScreen | 2020 |
| † | K211541 | MammoScreen 2.0 | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260714 | MammoScreen® (5) | 2026 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K260714 (Therapixel, 2026) has gone furthest, with 0 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. 2025, 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 4 is a concurrent reading and reporting aid for physicians interpreting screening mammograms. It is intended for use with compatible full-field digital mammography and digital breast tomosynthesis systems. The device can also use compatible prior examinations in the analysis. Output of the device includes graphical marks of findings as soft-tissue lesions or calcifications on mammograms along with their level of suspicion scores. The lesion…
Read the full statement (137 words)
MammoScreen 4 is a concurrent reading and reporting aid for physicians interpreting screening
mammograms. It is intended for use with compatible full-field digital mammography and digital
breast tomosynthesis systems. The device can also use compatible prior examinations in the
analysis.
Output of the device includes graphical marks of findings as soft-tissue lesions or calcifications on
mammograms along with their level of suspicion scores. The lesion type is characterized as
mass/asymmetry, distortion, or calcifications for each detected finding. The level of suspicion score
is expressed at the finding level, for each breast, and overall for the mammogram.
The location of findings, including quadrant, depth, and distance from the nipple, is also provided.
This adjunctive information is intended to assist interpreting physicians during reporting.
Patient management decisions should not be made solely based on the analysis by MammoScreen
4.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243679: MammoScreen® (4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243679
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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