510(k) · Cleared
ClearedLunit INSIGHT MMG (v1.1.10)
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 Apr 23, 2026 as substantially equivalent to K211678 (Lunit, Inc., 2021) after an 83-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Apr 23, 2026
- Review
- 83 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- 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 deviceK260320 Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
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 6…Lunit INSIGHT MMG Version v1.1.6 Legal manufacturer Lunit Inc. 510(k) number K211678 Radiological Computer Assisted Detection/Diagnosis Software For Suspicious Classification… | 2021 |
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 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- 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. 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?
Lunit INSIGHT MMG is a radiological Computer-Assisted Detection/ Diagnosis (CADe/x) software device based on an artificial intelligence algorithm intended to aid in the detection, localization, and characterization of suspicious areas for breast cancer on mammograms from compatible FFDM systems.
As an adjunctive tool, the device is intended to be viewed by interpreting physicians after completing their initial read. It is not intended as a replacement for a complete physician’s review or their clinical judgement that takes into account other relevant information from the image or patient history. The Lunit INSIGHT MMG uses screening mammograms of the female population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260320: Lunit INSIGHT MMG (v1.1.10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260320
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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