FDA Radiology AI Devices

Volpara Imaging Software is a medical imaging application designed to analyze digital mammography and tomosynthesis images. It generates detailed breast density maps and calculates volumetric breast density, helping healthcare professionals assess breast tissue composition. The software provides numerical breast density values and BI-RADS categories as adjunctive information, supporting the diagnostic process.

Quantra is a software application used with digital breast x-ray images to calculate volumetric and area breast density. It aids radiologists by providing quantitative breast tissue composition data to help in consistent breast density reporting. It does not interpret images directly but supports breast cancer risk assessment and reporting.

CVI42 is a software tool designed for analyzing CT and MR images of blood vessels. It provides tools for image visualization, processing, vessel centerline and lumen calculations, stenosis evaluation, and lesion characterization. This helps physicians evaluate and track vascular lesions more effectively for improved patient diagnosis and management.

ClearRead +Confirm is a software application that creates enhanced secondary digital chest X-ray images to help healthcare professionals confirm the placement of lines and tubes. This improves visibility on standard chest radiographs, aiding in timely and accurate patient management.

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.