FDA Radiology AI Devices

1CMR Pro is a medical software tool that helps clinicians view and analyze cardiovascular MRI images. It automates analysis of heart structure, function, and blood flow, improving the accuracy and precision of cardiac assessments. This supports better diagnosis and monitoring of heart diseases.

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.

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.

uOmnispace.MI is an advanced software platform designed to help healthcare professionals view and analyze medical images from PET, CT, MR, and SPECT scans. It facilitates tasks such as image registration, lesion segmentation, and statistical analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications including fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, thereby assisting clinicians in making timely and accurate diagnoses.

StrokeViewer Perfusion is a software package designed to analyze dynamic brain CT perfusion scans to provide quantitative information about blood flow and volume in brain tissue. It aids medical professionals by visualizing perfusion maps and numerical data to assist in the evaluation of suspected ischemic stroke patients. The software supports clinicians by generating additional imaging data to inform diagnosis and treatment decisions without replacing clinical judgment.

Veuron-Brain-pAb3 is advanced software that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentration as an aid in diagnosing dementia. It automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, improving diagnostic accuracy and workflow efficiency.

Jazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.

NEUROShield is a software tool that automatically labels, visualizes, and measures the volume of the hippocampus brain structure using 3D MRI images. It uses AI deep learning models to assist neurologists and neuroradiologists by providing fast, accurate volumetric analysis, helping in clinical decision-making and research.

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.