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 (v3) is a software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. It automatically analyzes certain brain regions to generate an ASPECT Score, which helps characterize ischemic damage. This tool supports radiologists by providing standardized, AI-derived scores and annotated images, facilitating accurate and consistent stroke assessment to inform treatment decisions.

FDA #
K232156
Product Code
POK

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

FDA #
K233512
Product Code
QIH

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

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
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