FDA Radiology AI Devices

Transpara Density 1.0.0 is an AI-powered software designed to assist healthcare professionals in assessing breast tissue composition from digital mammography and tomosynthesis images. It automatically calculates volumetric breast density, breast volume, and categorizes breast density according to ACR BI-RADS 5th Edition. This helps radiologists make informed decisions about breast cancer screening and diagnosis.

ViewFinder Software Version 1.1 by Elaitra Ltd is a specialized software tool designed for clinicians to review digital breast tomosynthesis images. It dynamically matches tissue across different breast views using AI to reduce cognitive load, helping radiologists to compare images more efficiently and accurately during breast cancer screening and diagnosis.

Saige-Density is a medical software that uses AI deep learning techniques to analyze digital mammograms, producing breast density categories based on ACR BI-RADS guidelines. It helps radiologists assess breast tissue composition by providing adjunctive information, improving breast cancer risk assessment and screening interpretation.

ClariSIGMAM is a software tool designed to automatically analyze digital mammograms to estimate breast density by calculating the ratio of fibroglandular tissue to the total breast area. It categorizes breast density using BI-RADS groups to assist radiologists in assessing breast tissue composition, providing adjunctive information to support interpretation but is not a diagnostic aid.

PowerLook Density Assessment V4.0 is a software tool that analyzes synthetic 2D images from digital breast tomosynthesis exams to provide breast density categories using the ACR BI-RADS 5th Edition. This helps radiologists assess breast tissue composition as an adjunctive aid, improving breast cancer screening processes.

Visage Breast Density is a software application designed to analyze mammography images and classify breast density into categories according to the ACR BI-RADS Atlas 5th Edition. It uses a convolutional neural network to assist radiologists by providing adjunctive information about breast tissue composition, making breast density assessment more efficient.