# K260320: Lunit INSIGHT MMG (v1.1.10)

- Pathway: 510(k) (Special)
- Applicant: Lunit, Inc.
- Decided: Apr 23, 2026 after 83 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211678: Lunit INSIGHT MMG, Lunit, Inc. (2021) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K260320
Methodology: https://510kreport.com/methodology