FDA Radiology AI Devices

MRCP+ v1.0 is a standalone software device from Perspectum Diagnostics that assists trained operators in the quantitative, non-invasive assessment of the biliary system using MR imaging data. It automatically generates 3D models of the biliary tree, measures bile duct widths, detects regions of variation, and provides tools for segmentation and volumetric analysis. This helps radiologists and clinicians better visualize and evaluate hepatobiliary structures, potentially improving diagnosis and patient care in biliary system diseases.

AmCAD-UO is a software application designed to analyze ultrasound images of the upper airway. It helps physicians visualize and quantify airway size, position, and tissue characteristics to monitor airway conditions more effectively. It supports manual and interactive region selection for detailed analysis and is intended to assist clinical evaluation, not to be used as a sole diagnostic tool.

Quantib ND is an AI-powered software that processes MRI brain scans to automatically identify and measure volumes of various brain structures and white matter hyperintensities. It provides 3D visualizations and quantitative data to assist medical professionals in evaluating brain images and supporting quantitative reporting, making brain MR image assessment more precise and efficient.

vascuCAP is a medical image analysis software designed to help clinicians process and evaluate multidimensional CT images of arterial vessels. It provides tools to visualize vessels in 3D and measure key anatomical features such as lumen boundaries, vessel stenosis, and plaque characteristics. This assists physicians in stratifying patients with atherosclerosis by providing detailed vessel information to complement standard care.

Vitrea CT Brain Perfusion is a software tool that processes CT imaging data to calculate and visualize brain blood flow parameters. It helps physicians assess brain perfusion in patients with acute stroke by highlighting areas with decreased blood flow, supporting clinical decision-making.

icobrain is an AI-powered software that automates the identification, labeling, and volume measurement of brain structures from MR and CT images. It assists clinicians in evaluating brain conditions such as dementia and traumatic brain injury by providing detailed volumetric reports and visual overlays, improving the efficiency and accuracy of brain image analysis.

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.

Arterys Oncology DL is a medical imaging software that helps clinicians view, compare, and analyze CT and MR images to detect and track lesions in cancer patients. It offers tools for 2D and 3D visualization, semi-automatic segmentation of lung nodules and liver lesions, and longitudinal tracking to support diagnosis and treatment follow-up.

cNeuro cMRI is a software tool designed to automatically identify, label, quantify, and visualize brain structures from MRI scans. It helps medical professionals by automating manual processes in brain image analysis, improving efficiency in the assessment of brain volumes and abnormalities compared to a healthy reference population.