FDA & CE | Breast | DBT | Amplifier Partner

Description of 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 suspicious lesions for breast cancer in digital breast tomosynthesis (DBT) exams. 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 as well as for each breast.

The product is intended for use in screening digital breast tomosynthesis images to identify and characterize suspicious areas for breast cancer for interpreting physicians’ review.

The application content is provided by the respective AI vendors.