# K242652: Lunit INSIGHT DBT v1.1

- Pathway: 510(k) (Special)
- Applicant: Lunit, Inc.
- Decided: Oct 4, 2024 after 30 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: 5 generations back to DEN180005 (2018). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231470: Lunit INSIGHT DBT, Lunit, Inc. (2023) Summary page 6.

## Most influential descendants
- K261517: qCT Lung (v1.0) (2026), 0 descendants of its own
- K253796: Lunit INSIGHT DBT (V1.2) (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K242652
Methodology: https://510kreport.com/methodology