510(k) · Cleared
ClearedLunit INSIGHT MMG
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 17, 2021 as substantially equivalent to K192287 (Screenpoint Medical B.V., 2019) after a 169-day review. Its family tree reaches back 3 generations to 2018. 5 later devices descend from it.
- Decided
- Nov 17, 2021
- Review
- 169 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 2 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 1 generation backK192287 TransparaScreenpoint Medical B.V. · 2019
- This deviceK211678 Lunit INSIGHT MMGLunit, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK231470 Lunit INSIGHT DBTLunit, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK242652 Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261517 qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK260320 Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK253796 Lunit INSIGHT DBT (V1.2)Lunit, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K231470Lunit INSIGHT DBTLunit, Inc. · 2023 · cites it directly3descendants
- K242652Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024 · 2 generations on2descendants
- K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd. · 2026 · 3 generations on0descendants
- K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · 2026 · cites it directly0descendants
- K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −2 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −1 | K192287 | Transpara | Screenpoint Medical B.V. | 2019 | — |
| 0 (this device) | K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021 | — |
| +1 | K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023 | — |
| +2 | K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024 | — |
| +3 | K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt., Ltd. | 2026 | — |
| +1 | K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | 2026 | — |
| +3 | K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K192287 | TransparaSummary page 5…Product Code: QDQ III. PREDICATE DEVICE Predicate Device Manufacturer Name: Screenpoint Medical B.V. Device Trade Name: TransparaTM 510(k) Number: K192287 IV. DEVICE DESCRIPTION Lunit INSIGHT MMG is a radiological Computer-Assisted Detection and Diagnosis (CADe/x) software for aidi… | 2019 |
What descends from it? (5)
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 3 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231470 (Lunit, Inc., 2023) has gone furthest, with 3 descendants of its own.
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. 2021, 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 and 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. Lunit INSIGHT MMG uses screening mammograms of the female population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211678: Lunit INSIGHT MMG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211678
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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