510(k) · Cleared
ClearedTranspara 1.7.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Screenpoint Medical B.V. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Jun 2, 2021 as substantially equivalent to K193229 (Screenpoint Medical B.V., 2020) after a 112-day review. Its family tree reaches back 3 generations to 2018. 5 later devices descend from it.
- Decided
- Jun 2, 2021
- Review
- 112 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). 5 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 backK193229 TransparaScreenpoint Medical B.V. · 2020
- This deviceK210404 Transpara 1.7.0Screenpoint Medical B.V. · 2021
- Descendant · cites it directly · 4 of its ownK221347 Transpara 1.7.2Screenpoint Medical B.V. · 2022
- Descendant · 2 generations on · 2 of its ownK241831 Transpara (2.1.0)Screenpoint Medical B.V. · 2024
- Descendant · 3 generations on · 0 of its ownK260898 Transpara (2.1.0)Screenpoint Medical B.V. · 2026
- Descendant · 3 generations on · 0 of its ownK251474 Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK230096 Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K221347Transpara 1.7.2Screenpoint Medical B.V. · 2022 · cites it directly4descendants
- K241831Transpara (2.1.0)Screenpoint Medical B.V. · 2024 · 2 generations on2descendants
- K260898Transpara (2.1.0)Screenpoint Medical B.V. · 2026 · 3 generations on0descendants
- K251474Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies · 2026 · 3 generations on0descendants
- K230096Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc. · 2023 · 2 generations on0descendants
View 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 | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| 0 (this device) | K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021 | — |
| +1 | K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022 | — |
| +2 | K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024 | — |
| +3 | K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2026 | — |
| +3 | K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | 2026 | — |
| +2 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221347 | Transpara 1.7.2 | 2022 | 4 |
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 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221347 (Screenpoint Medical B.V., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K193229.
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?
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
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/K210404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210404: Transpara 1.7.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210404
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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