FDA Radiology AI Devices

AlphaPoint Imaging Software is a tool that helps clinicians review and analyze CT chest images by providing segmentation and numerical analysis of tissue types. It assists in identifying different substances in the images and generates preliminary reports to support medical decision-making.

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.