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.

Ziostation2 is an advanced medical image processing software that supports multiple imaging modalities including CT, MRI, Ultrasound, and X-ray. It helps clinicians view and analyze medical images by providing tools for image quantification, manipulation, and communication. This software is designed to enhance the workflow and diagnostic process for radiologists and other trained medical professionals.

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.

Quantitative Total Extensible Imaging (QTxI) is a software tool that helps medical professionals manage and evaluate digital medical images from CT and PET scans. It supports tasks such as storing, retrieving, and displaying images, as well as identifying and analyzing regions of interest (ROIs) in full or partial body scans with 3D visualization. This software aids clinicians by automating quantification and monitoring changes in imaging data to improve diagnostic and treatment decision workflows.

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.

EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.

Viz CTP is a software package that processes and analyzes CT perfusion scans of the brain to calculate parameters related to tissue blood flow and volume. It helps clinicians by providing detailed brain perfusion maps that assist in diagnosing and managing neurological conditions, improving clinical decision-making.

Quantib Brain is a software application that automatically labels, visualizes, and measures brain structures and white matter lesions on MRI scans. It helps trained medical professionals by providing quantitative information to assist in the evaluation and assessment of brain MR images, supporting more informed and quantitative reporting in clinical settings.

iQMR is a software package designed to enhance MRI images by reducing noise and improving image quality. It operates on a PC server connected to a network, receiving and transmitting MRI images in DICOM format. This helps medical professionals get clearer images for better diagnosis and analysis.

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.