FDA Radiology AI Devices

Arterys MICA is a software platform designed to display, process, store, and transfer medical imaging data, including CT and MR images. It features modules specialized for cardiac and oncology workflows, providing quantitative analysis to aid clinicians in diagnosis. The software runs on standard computers via a web browser and supports enhanced image viewing and lesion evaluation for clinical decision support.

Volpara Imaging Software is a tool designed to analyze raw digital mammography and tomosynthesis images to calculate volumetric breast density. It provides quantitative measurements and density maps to assist healthcare professionals in evaluating breast tissue composition. The software operates on a Windows server outside the patient environment and supports clinical decision-making by providing adjunctive information on breast density, aiding in breast cancer screening assessments.

DenSeeMammo is a software tool designed to assist radiologists by automatically estimating breast density from digital mammography images. It analyzes 2D mammograms and categorizes breast density according to the BI-RADS 5th Edition, providing additional information to aid breast cancer risk assessment. The final breast density assessment remains the responsibility of the qualified physician. This helps clinicians make consistent and informed evaluations of breast density, potentially improving screening and diagnosis.

DM-Density is an AI-based software that processes digital mammogram images to automatically calculate breast density, providing numerical values and breast density grades to assist physicians in assessing breast tissue composition. It supports clinical use by delivering standardized breast density information following BI-RADS classifications, integrating with mammography workstations or PACS.

Quantra is a software tool designed to analyze digital mammographic images and estimate breast tissue composition. It categorizes breast density in a way that aligns with BI-RADS breast composition reporting standards to help radiologists assess breast tissue, aiding consistent reporting for breast cancer screening and diagnosis support, though it is not a diagnostic aid itself.

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.

AmCAD-UV is a software tool designed to analyze flow Doppler ultrasound images by classifying ultrasonic color intensity data into different pulsatile signals. It helps clinicians visualize and evaluate vascular pulsatility by providing color-coded images and trend charts of pulsatile signals, although it is not intended for primary diagnostic use by itself.

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.

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.