OMB Individually Reported
Koios
High riskExact public inventory row
Description
FDA Cleared. Used with Automated Breast Ultrasound (ABUS). Classifies breast ultrasound lesions and automates reporting for improved efficiency and streamlined workflows. Increased sensitivity and specificity with reduced variability.
Detailed example
Classifies breast ultrasound lesions
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
a) Pre-deployment – The use case is in a development or acquisition status.
Expected benefit
Reduces unnecessary treatments (existing BI-RADS 3's can be accurately and safely downgraded) and provides probability of malignancy aligned to BI-RADS categorization.
Controls / human review
ATO: Not reported; PIA: Not published