510(k) · Cleared
ClearedTranspara
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 Mar 5, 2020 as substantially equivalent to K181704 (Screenpoint Medical B.V., 2018) after a 104-day review. Its family tree reaches back 2 generations to 2018. 9 later devices descend from it.
- Decided
- Mar 5, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 1 generation backK181704 TransparaScreenpoint Medical B.V. · 2018
- This deviceK193229 TransparaScreenpoint Medical B.V. · 2020
- Descendant · cites it directly · 5 of its ownK210404 Transpara 1.7.0Screenpoint Medical B.V. · 2021
- Descendant · 2 generations on · 4 of its ownK221347 Transpara 1.7.2Screenpoint Medical B.V. · 2022
- Descendant · 3 generations on · 2 of its ownK241831 Transpara (2.1.0)Screenpoint Medical B.V. · 2024
- Descendant · cites it directly · 2 of its ownK212783 ProstatIDScanmed, LLC · 2022
- Descendant · 4 generations on · 0 of its ownK260898 Transpara (2.1.0)Screenpoint Medical B.V. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K210404Transpara 1.7.0Screenpoint Medical B.V. · 2021 · cites it directly5descendants
- K221347Transpara 1.7.2Screenpoint Medical B.V. · 2022 · 2 generations on4descendants
- K241831Transpara (2.1.0)Screenpoint Medical B.V. · 2024 · 3 generations on2descendants
- K212783ProstatIDScanmed, LLC · 2022 · cites it directly2descendants
- K260898Transpara (2.1.0)Screenpoint Medical B.V. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −1 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| 0 (this device) | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| +1 | K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021 | — |
| +2 | K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022 | — |
| +3 | K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024 | — |
| +1 | K212783 | ProstatID | Scanmed, LLC | 2022 | — |
| +4 | K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210404 (Screenpoint Medical B.V., 2021) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K181704.
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. 2020, 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 as stated in the FDA summary.
https://510kreport.com/device/K193229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193229: Transpara.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193229
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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