FDA Radiology AI Devices

The Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.

RBknee is an AI-powered software that automatically analyzes knee X-ray images to measure joint space width and assess signs of knee osteoarthritis. It provides objective measurements and standardized grading to help medical professionals in evaluating knee osteoarthritis severity, supporting diagnosis and treatment decisions.

Volpara Imaging Software is an AI-driven tool that processes raw digital mammography and tomosynthesis images to generate detailed breast density maps and quantitative metrics. It helps healthcare professionals assess breast composition by providing volumetric measurements and BI-RADS density categories as adjunctive information in breast cancer screening and assessment.

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

Densitas densityai is a software application that analyzes digital mammography and breast tomosynthesis images to automatically assess breast tissue density. It provides a Breast Density Grade according to the American College of Radiology's BI-RADS 5th Edition to assist physicians in evaluating breast composition. This adjunctive tool helps interpret breast density consistently and efficiently, enhancing clinical decision-making in breast cancer screening.

iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.

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.