FDA Radiology AI Devices

DeltaView Model 2.1 is a software tool that processes current and prior chest x-ray images of the same patient to create a difference image highlighting areas of change. This assists radiologists in detecting lung nodules that have changed over time, improving diagnostic accuracy without replacing the original x-ray images.

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.

IB Neuro v1.0 is software that processes MRI data to create maps showing blood flow and volume in the brain. These maps help doctors evaluate brain perfusion and may assist in clinical decision-making. The software integrates easily with existing MRI systems and PACS to streamline the workflow for clinicians.

The BioPlex 2200 ANA Screen with Medical Decision Support Software (MDSS) is a laboratory tool that assists clinicians by analyzing patterns in antibody test results from human serum or plasma samples. Using AI principles (k-nearest neighbor algorithm), it compares patient antibody profiles against a large database to suggest associations with specific systemic autoimmune diseases such as lupus, scleroderma, Sjögren's syndrome, and polymyositis. This software helps improve diagnostic accuracy and guides additional testing decisions.