FDA Radiology AI Devices

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

Autoplaque 3.0 is a post-processing software designed for use with coronary CT angiography images. It helps cardiologists and radiologists analyze coronary arteries to detect and measure plaques and stenosis. The AI-driven software automates vessel, plaque, and lumen segmentation with an option for clinician review, enabling faster and more standardized cardiac image analysis.

SubtleMR (2.3.x) is an AI-powered software that improves MRI images by reducing noise or enhancing sharpness. It supports MRI scans of various body regions such as head, spine, abdomen, and more. This helps clinicians obtain clearer images, potentially improving diagnostic accuracy without additional scans or equipment.

Neurophet AQUA is a software tool that helps clinicians and researchers analyze brain MRI scans by automatically identifying and measuring brain structures. It generates detailed reports comparing patient brain volumes to reference data, aiding in the assessment of neurological conditions and monitoring structural brain changes.

MR DWI/FLAIR Measurement V1.0 is a medical image processing software developed by Olea Medical that analyzes MRI brain images from diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences. It automatically computes diffusion maps and extracts relevant metrics to assist medical professionals in evaluating brain conditions. The software integrates with existing medical imaging platforms and helps clinicians by providing quantitative analysis to complement their diagnosis and treatment planning.

Quantib Prostate is a software tool that helps medical professionals analyze prostate MRI images. It automatically segments the prostate and its subregions, supports visualization with multiparametric MRI, and assists in identifying and editing potential lesions. By streamlining these tasks, it aids radiologists in interpreting prostate MRI studies more efficiently and effectively.

Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.

Limbus Contour is a software tool that automatically segments CT and MRI images to help radiation oncologists, dosimetrists, and medical physicists create precise contours of healthy anatomical structures. These contours are used as inputs for radiation treatment planning, improving accuracy and efficiency in therapy. The software integrates with existing treatment planning systems and image viewers, assisting in contour creation, modification, and management without displaying images directly.

FlightPlan for Embolization by GE Medical Systems SCS is a software application that processes 3D X-ray angiography images to help clinicians visualize blood vessels during the planning phase of embolization procedures. It uses AI-powered algorithms to automatically segment vasculature and define root points, assisting physicians in better treatment planning. This enhances clinical decision-making but is not intended for use during the delivery of therapy itself.

The Xeleris V Processing and Review System by GE Healthcare is a software platform designed for processing, reviewing, and analyzing nuclear medicine and PET imaging data. It supports various clinical applications including brain, lung, cardiac, liver, and bone imaging analyses, aiding physicians in diagnosis and treatment planning by providing enhanced image visualization, quantification, and monitoring of patient radiation doses.