FDA Radiology AI Devices

MammoScreen BD is an AI-powered software designed to assist radiologists by automatically analyzing mammography images. It helps detect and assess breast density, improving the accuracy and consistency of breast cancer screening and diagnosis.

Genius AI Detection 2.0 is a software tool that uses artificial intelligence and deep learning to help radiologists detect and evaluate potential breast abnormalities in 3D mammography (digital breast tomosynthesis) images. It marks suspicious soft tissue densities and calcifications, provides confidence scores, and supports radiologists in their interpretation during the exam reading, enhancing breast cancer screening accuracy and efficiency.

HESTIA is a full field digital mammographic x-ray system designed to assist clinicians in capturing detailed breast images for screening and diagnosis. This technology helps detect breast abnormalities, making it a valuable tool in breast cancer diagnosis and management.

MammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.

The 2430TCA with Xmaru W is a digital flat panel X-ray detector system designed for mammographic screening. It replaces traditional film or screen-based mammographic systems by capturing and digitizing high-quality breast images, assisting clinicians in breast cancer screening with enhanced image quality and reduced noise.

VIVIX-M is a series of advanced flat panel detectors designed for digital mammography. These detectors capture high-quality digital X-ray images of the breast to assist clinicians in screening and diagnosing breast conditions. The system processes the X-ray signals into detailed digital images compatible with medical imaging workflows, supporting effective and accurate mammography examinations.

Saige-Density is a software tool that analyzes digital mammography and breast tomosynthesis images to categorize breast density according to the ACR BI-RADS Atlas 5th Edition. It aids radiologists by providing adjunctive information to help assess breast tissue composition, improving the evaluation process, although it is not a diagnostic aid itself.

Saige-Dx (3.1.0) is an AI-based software designed to assist radiologists by analyzing digital breast tomosynthesis mammograms to detect suspicious soft tissue lesions and calcifications indicative of cancer. It evaluates 3D and 2D mammogram images, assigning suspicion levels for findings and cases, and produces reports to support concurrent reading. This helps clinicians improve detection accuracy and reduce reading time in breast cancer screening for women aged 35 and older.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.