FDA Radiology AI Devices

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.

Accipiolx is an artificial intelligence software tool designed to automatically analyze non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It integrates into hospital radiology networks to prioritize cases suggesting hemorrhage, enabling quicker review by clinicians and faster treatment decisions in acute care settings.

BriefCase is an AI-powered software that assists radiologists by analyzing non-enhanced head CT images to detect suspected intracranial hemorrhages. It provides timely notifications with preview images to prioritize cases for faster review, helping clinicians improve workflow efficiency and patient care without altering original images or making diagnoses.

Workflow Box by Mirada Medical Ltd is a software system that helps route medical imaging data and automatically applies contouring to images like CT and MRI. It uses advanced methods including deformable image registration and machine learning to assist clinicians in creating detailed anatomical outlines for radiation therapy planning. The software integrates with other visualization tools to allow medical professionals to review and adjust automatically generated contours.

HealthCCS is a software tool that uses cardiac CT images to automatically identify and measure calcified plaques in the coronary arteries. This helps physicians assess coronary artery disease risk by providing a calcium score and risk category report based on pre-existing CT scans, aiding further clinical decisions and patient management.

LungQ by Thirona Corporation is a software tool that processes CT chest scans to help physicians quantitatively analyze pulmonary tissues. It performs 3D segmentation of lung regions, volumetric and density evaluations, fissure analysis, and generates reports to support diagnosis and monitoring of lung conditions.

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.

Radiomics App v1.0 by Microsoft is a software tool designed to help trained radiation oncologists, dosimetrists, and physicists create precise three-dimensional contours of tumors and healthy anatomical structures in CT and MRI scans. This assists in radiation treatment planning by providing optimized organ and tumor segmentation, supporting improved treatment evaluation and planning workflows.

The LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.

CT CoPilot is an AI-powered software designed for automatic labeling, visualization, and volume measurement of brain structures from CT scans. It helps radiologists by automating the manual process of analyzing brain CT images, providing detailed segmentation and volumetric data to assist in clinical assessments and comparisons across multiple imaging sessions.