510(k) · Cleared
ClearedLunit INSIGHT DBT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunit, Inc. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Nov 6, 2023 as substantially equivalent to K211678 (Lunit, Inc., 2021) after a 168-day review. Its family tree reaches back 4 generations to 2018. 3 later devices descend from it.
- Decided
- Nov 6, 2023
- Review
- 168 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN180005 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 3 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 2 generations backK192287 TransparaScreenpoint Medical B.V. · 2019
- 1 generation backK211678 Lunit INSIGHT MMGLunit, Inc. · 2021
- This deviceK231470 Lunit INSIGHT DBTLunit, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK242652 Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261517 qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253796 Lunit INSIGHT DBT (V1.2)Lunit, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −3 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −2 | K192287 | Transpara | Screenpoint Medical B.V. | 2019 | — |
| −1 | K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021 | — |
| 0 (this device) | K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023 | — |
| +1 | K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024 | — |
| +2 | K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt., Ltd. | 2026 | — |
| +2 | K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211678 | Lunit INSIGHT MMGSummary page 5…n 21 CFR 892.2090 Regulatory Class Class II Product Code QDQ Submission Number K211678 3. Device Description Lunit INSIGHT DBT is a computer-assisted detection/diagnosis (CADe/x) software as a medical device th… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242652 | Lunit INSIGHT DBT v1.1 | 2024 | 2 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K242652 (Lunit, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K211678.
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. 2023, 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?
Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems. Through the analysis, the regions of soft tissue lesions and calcifications are marked with an abnormality score indicating the likelihood of the presence of…
Read the full statement (112 words)
Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to
be used concurrently by interpreting physicians to aid in the detection and characterization of
suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible
DBT systems. Through the analysis, the regions of soft tissue lesions and calcifications are marked
with an abnormality score indicating the likelihood of the presence of malignancy for each lesion.
Lunit INSIGHT DBT uses screening mammograms of the female population.
Lunit INSIGHT DBT is not intended as a replacement for a complete interpreting physician’s review
or their clinical judgment that takes into account other relevant information from the image or
patient history.
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/K231470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231470: Lunit INSIGHT DBT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231470
Report an extraction error
Are you the manufacturer?
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