FDA Radiology AI Devices

RayStation is a software system designed to assist radiation therapy staff in planning and analyzing radiation treatments. It uses patient imaging data from CT, PET, and MRI scans to create detailed treatment plans that optimize radiation delivery while protecting healthy tissue. The system includes features like image fusion, contouring, dose computation, and machine learning to optimize and adapt treatment plans efficiently, helping clinicians deliver precise and effective cancer therapy.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.

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.

The AMRA Profiler is a medical imaging system that utilizes MRI technology to assess body composition. It helps clinicians by providing detailed imaging data that supports diagnostics or treatment planning in radiology.

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.

The NvisionVLE Imaging System by NinePoint Medical, Inc. is a high-resolution optical coherence tomography (OCT) imaging device designed to visualize tissue microstructures, especially in the esophagus. It uses a specialized probe and advanced imaging software to provide clinicians with real-time, cross-sectional images of tissue, enhanced by AI-based segmentation to color-highlight important features. This helps clinicians better review and mark areas of interest in the tissue during evaluation, aiding in diagnosis and treatment planning.