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 Nov 21, 2018 as substantially equivalent to DEN180005 (Imagen Technologies, Inc., 2018) after a 147-day review. Its family tree reaches back 1 generation to 2018. 32 later devices descend from it.
- Decided
- Nov 21, 2018
- Review
- 147 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180005 (2018). 32 later devices descend from it, 6 citing it directly.
- Root · 1 generation backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- This deviceK181704 TransparaScreenpoint Medical B.V. · 2018
- Descendant · cites it directly · 9 of its ownK193229 TransparaScreenpoint Medical B.V. · 2020
- Descendant · cites it directly · 6 of its ownK192287 TransparaScreenpoint Medical B.V. · 2019
- Descendant · 2 generations on · 5 of its ownK211678 Lunit INSIGHT MMGLunit, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK210404 Transpara 1.7.0Screenpoint Medical B.V. · 2021
- Descendant · 3 generations on · 4 of its ownK221347 Transpara 1.7.2Screenpoint Medical B.V. · 2022
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K193229TransparaScreenpoint Medical B.V. · 2020 · cites it directly9descendants
- K192287TransparaScreenpoint Medical B.V. · 2019 · cites it directly6descendants
- K211678Lunit INSIGHT MMGLunit, Inc. · 2021 · 2 generations on5descendants
- K210404Transpara 1.7.0Screenpoint Medical B.V. · 2021 · 2 generations on5descendants
- K221347Transpara 1.7.2Screenpoint Medical B.V. · 2022 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| 0 (this device) | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| +1 | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| +1 | K192287 | Transpara | Screenpoint Medical B.V. | 2019 | — |
| +2 | K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021 | — |
| +2 | K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021 | — |
| +3 | K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | DEN180005 | OsteoDetectSummary page 7…isk 5-40 Management To Medical Devices IEC 62304:2015 Medical Device Software - Software Life 13-79 Cycle Processes DEN180005 Evaluation of automatic class III N/A designation for OsteoDetect – Decision… | 2018 |
What descends from it? (32)
See all 326 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?
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. 2018, 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?
The ScreenPoint Transpara™ system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications; region‐based scores, displayed upon the physician’s query, indicating the likelihood that cancer is present in specific regions; and an overall score indicating the likelihood that cancer is present on the mammogram. 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/K181704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181704: Transpara.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181704
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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