510(k) · Cleared
ClearedTranspara (2.1.0)
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 Aug 14, 2026 as substantially equivalent to K241831 (Screenpoint Medical B.V., 2024) after a 149-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Aug 14, 2026
- Review
- 149 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 5 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 4 generations backK193229 TransparaScreenpoint Medical B.V. · 2020
- 3 generations backK210404 Transpara 1.7.0Screenpoint Medical B.V. · 2021
- 2 generations backK221347 Transpara 1.7.2Screenpoint Medical B.V. · 2022
- 1 generation backK241831 Transpara (2.1.0)Screenpoint Medical B.V. · 2024
- This deviceK260898 Transpara (2.1.0)Screenpoint Medical B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −5 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −4 | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| −3 | K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021 | — |
| −2 | K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022 | — |
| −1 | K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024 | — |
| 0 (this device) | K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2026 | — |
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 |
|---|---|---|---|
| * | K241831 | Transpara (2.1.0)Summary page 6…892.2090 Panel Radiology Device class II Product code QDQ Clearance number K241831 4. Device description Transpara is a software only application designed to be used by physicians to improve interpretati… | 2024 |
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 8 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K241831.
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. 2026, 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/K260898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260898: Transpara (2.1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260898
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026