FDA Radiology AI Devices

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

nordicMEDiVA is an advanced software platform designed to analyze and visualize functional and dynamic MRI data of the brain. It automates image processing pipelines and provides clinicians with derived imaging parameters through a web-browser interface, facilitating the evaluation of brain function and structure to aid clinical decision-making.

SIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.

JLK-CTP is an image processing software that helps trained medical professionals analyze brain CT perfusion images. It automatically receives, processes, and visualizes dynamic CT perfusion datasets to calculate blood flow and volume parameters, aiding in the assessment of cerebral blood flow and tissue status in brain imaging.

VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.

JBS-LVO is an AI-powered radiological software tool designed to analyze CT angiograms of the brain to detect suspected large vessel occlusions (LVOs). It notifies neurovascular specialists quickly via mobile app notifications to aid in rapid patient triage, supporting timely treatment decisions. The software provides compressed preview images for informational purposes, while diagnosis is made by specialists reviewing full-resolution scans.

uAI Easy Triage ICH is an AI-powered software designed to assist radiologists by analyzing non-contrast head CT images to detect suspected intracranial hemorrhage (ICH). It helps prioritize and triage cases by flagging images that show possible bleeding in the brain, ensuring faster notification and workflow efficiency in hospital settings.