FDA Radiology AI Devices

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.

ClearView cCAD is an AI-powered software tool that helps physicians analyze breast ultrasound images by automatically classifying lesion shape and orientation characteristics. It supports better screening and diagnosis by generating reports compliant with ACR BI-RADS standards, aiding radiologists in their assessment without replacing primary diagnostic interpretation.

QVCAD System by QView Medical, Inc. is a specialized AI software that aids radiologists in detecting breast lesions in 3D automated breast ultrasound images. It uses advanced image pattern recognition and neural networks to highlight suspicious areas that may indicate breast cancer, helping clinicians improve detection accuracy and reduce interpretation time during breast screening, especially for women with dense breasts.

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.

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.