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 Dec 10, 2019 as substantially equivalent to K181704 (Screenpoint Medical B.V., 2018) after a 110-day review. Its family tree reaches back 2 generations to 2018. 6 later devices descend from it.
- Decided
- Dec 10, 2019
- Review
- 110 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 1 generation backK181704 TransparaScreenpoint Medical B.V. · 2018
- This deviceK192287 TransparaScreenpoint Medical B.V. · 2019
- Descendant · cites it directly · 5 of its ownK211678 Lunit INSIGHT MMGLunit, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK231470 Lunit INSIGHT DBTLunit, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK242652 Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261517 qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260320 Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211678Lunit INSIGHT MMGLunit, Inc. · 2021 · cites it directly5descendants
- K231470Lunit INSIGHT DBTLunit, Inc. · 2023 · 2 generations on3descendants
- K242652Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024 · 3 generations on2descendants
- K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd. · 2026 · 4 generations on0descendants
- K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · 2026 · 2 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) | K192287 | Transpara | Screenpoint Medical B.V. | 2019 | — |
| +1 | K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021 | — |
| +2 | K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023 | — |
| +3 | K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024 | — |
| +4 | K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt., Ltd. | 2026 | — |
| +2 | K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181704 | TransparaSummary page 5…de QDQ Submission type Traditional 510(k) 3. Legally marketed predicate device Device trade name Transpara™ 1.3.0 (K181704) Legal Manufacturer ScreenPoint Medical B.V. Device Radiological Computer Assisted Detect… | 2018 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211678 | Lunit INSIGHT MMG | 2021 | 5 |
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 1 year and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211678 (Lunit, Inc., 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. 2019, 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 from compatible FFDM systems, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192287 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192287: Transpara.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192287
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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