FDA Radiology AI Devices

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.

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.

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.

TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.

TeraRecon Neuro is an AI-powered image processing software that analyzes brain perfusion data from CT or MRI scans. It helps healthcare professionals visualize blood flow and other key parameters in the brain to aid diagnosis, treatment planning, and post-treatment evaluation by providing detailed parametric maps and 3D visualizations of brain tissues and vessels.

ElucidVivo A.3 is a medical image analysis software that processes and visualizes CT angiographic images to help physicians assess arterial vessels and stratify patients with atherosclerosis. It offers tools for measurement and visualization of vessel structure and plaque characteristics, supporting clinical decision-making without providing direct diagnosis.

ClariPulmo is a software tool designed to analyze lung CT images. It helps doctors by automatically segmenting the lungs and quantifying areas of low and high attenuation in the lung tissue. It includes AI-based features like deep learning segmentation, denoising, and kernel normalization to improve image quality and quantification, especially for low-dose CT scans. This software supports clinical assessment of lung abnormalities by providing color-coded images and quantitative reports.

AIBOLIT 3D+ is a software system that takes CT scan images and processes them into detailed 3D visual models of anatomical structures. This tool helps doctors plan surgeries, train, and educate patients by enabling interactive viewing of organs and tissues from multiple angles and with enhanced clarity. It supports better decision-making and may reduce errors during procedures.

FlightPlan for Liver is a post-processing software that helps physicians analyze 3D X-ray angiography images to visualize the liver's vasculature and identify arteries near hypervascular lesions. It incorporates AI algorithms, including deep learning-based liver segmentation, to support the planning of liver embolization procedures, improving physician workflow and precision in treatment planning.

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.