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.

EchoSolv AS is a cloud-based AI and machine learning decision support software designed to help cardiologists assess severe aortic stenosis (AS) from transthoracic echocardiogram data and patient demographics. It provides a categorical probability of severe AS to assist in diagnosis alongside clinical guidelines, improving identification accuracy and supporting patient management decisions during echocardiogram interpretation.

FDA #
K241245
Product Code
POK
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