FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Rapid ASPECTS is an AI-powered software that helps doctors analyze CT brain scans to detect and score early signs of ischemic stroke by automatically segmenting brain regions and calculating an ASPECTS score. This aids clinicians in timely and accurate diagnosis, improving stroke assessment especially when expert radiologists are not immediately available.

FDA #
K200760
Product Code
POK

icobrain-ctp is a software package designed to analyze CT perfusion scans of the brain. It processes imaging data to calculate brain tissue perfusion parameters and volumes affected by abnormalities, providing detailed reports to aid clinicians in stroke and brain blood flow assessment. The tool supports image export in DICOM format and integrates with standard radiological viewing platforms, helping healthcare professionals make informed decisions efficiently.

FDA #
K192962
Product Code
LLZ

iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.

FDA #
K182130
Product Code
LLZ

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.

FDA #
K181247
Product Code
LLZ

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.

FDA #
K180161
Product Code
LLZ
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