FDA Radiology AI Devices

Genius AI Detection 2.0 with CC-MLO Correlation is an AI-powered software designed to assist radiologists by analyzing digital breast tomosynthesis images to detect and mark suspicious soft tissue densities and calcifications. It provides confidence scores for each detected lesion, helping clinicians interpret breast cancer screening exams more effectively, including correlation between different standard mammographic views for better diagnosis workflow.

Genius AI Detection 2.0 is a software device that uses deep learning AI models to analyze digital breast tomosynthesis (DBT) images. It identifies and marks suspicious soft tissue densities and calcifications, providing confidence scores to aid radiologists during breast cancer screening. The AI improves detection specificity and reduces false positives, supporting clinicians in interpreting 3D mammography exams efficiently and accurately.

Genius AI Detection is an AI software designed to assist radiologists by automatically identifying potential abnormalities such as masses and calcifications in digital breast tomosynthesis exams. It highlights suspicious regions on breast images, provides confidence scores, and helps improve diagnostic accuracy and workflow efficiency for breast cancer screening and diagnosis.

QUANTRA is software designed for use with digital mammography systems to estimate volumetric breast density. It calculates the ratio of fibroglandular tissue to total breast volume from mammography images, providing quantitative data to assist radiologists in assessing breast tissue composition. The software acts as an adjunct tool and is not intended as a diagnostic or interpretive aid, helping clinicians better understand breast density which is important for patient care.