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.

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.

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.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also support other applications such as fetal, abdominal, pediatric, vascular, and musculoskeletal imaging. These systems use ultrasound technology to produce detailed real-time images, including 3D and 4D imaging, helping clinicians diagnose and monitor various conditions effectively. The devices also feature enhanced workflow tools, advanced imaging options, and support comprehensive networking and data sharing capabilities, improving the efficiency and accuracy of ultrasound examinations.

Arterys MICA is a software platform designed to display, process, store, and transfer medical imaging data, including CT and MR images. It features modules specialized for cardiac and oncology workflows, providing quantitative analysis to aid clinicians in diagnosis. The software runs on standard computers via a web browser and supports enhanced image viewing and lesion evaluation for clinical decision support.

Ziostation2 is an advanced medical image processing software that supports multiple imaging modalities including CT, MRI, Ultrasound, and X-ray. It helps clinicians view and analyze medical images by providing tools for image quantification, manipulation, and communication. This software is designed to enhance the workflow and diagnostic process for radiologists and other trained medical professionals.

Volpara Imaging Software is a tool designed to analyze raw digital mammography and tomosynthesis images to calculate volumetric breast density. It provides quantitative measurements and density maps to assist healthcare professionals in evaluating breast tissue composition. The software operates on a Windows server outside the patient environment and supports clinical decision-making by providing adjunctive information on breast density, aiding in breast cancer screening assessments.

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.

Quantitative Total Extensible Imaging (QTxI) is a software tool that helps medical professionals manage and evaluate digital medical images from CT and PET scans. It supports tasks such as storing, retrieving, and displaying images, as well as identifying and analyzing regions of interest (ROIs) in full or partial body scans with 3D visualization. This software aids clinicians by automating quantification and monitoring changes in imaging data to improve diagnostic and treatment decision workflows.

The Uscan by EchoNous, Inc. is a handheld diagnostic ultrasound system designed for non-invasive imaging of the human body, including abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. It also features automated bladder volume measurement, assisting clinicians in quickly and accurately assessing patients without invasive procedures.