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.

Cardiac Guidance software helps medical professionals capture standard cardiac ultrasound views by providing real-time AI-powered guidance, quality feedback, and automatic image capture during echocardiography. It supports better image acquisition for accurate cardiac assessment, assisting clinicians during ultrasound exams.

FDA #
K243065
Product Code

Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that processes cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, a critical measure of heart function. It helps clinicians quickly and accurately evaluate cardiac health by analyzing ultrasound video clips, selecting the best quality views, and calculating ejection fraction with confidence metrics. This supports clinical decision-making in adult cardiac evaluations.

Product Code
QVD

The Caption Interpretation Automated Ejection Fraction Software is an AI-powered tool that automatically analyzes previously acquired cardiac ultrasound images to estimate the left ventricular ejection fraction. This helps clinicians assess heart function more efficiently and accurately by providing automated measurements, confidence metrics, and video clip visualizations within compatible ultrasound or PACS systems.

FDA #
K210747
Product Code
QIH

Caption Guidance is an AI-powered software accessory designed to assist medical professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance to help users obtain standard echocardiographic views, improving image quality and diagnostic accuracy.

FDA #
K201992
Product Code
QJU

The Caption Interpretation Automated Ejection Fraction Software uses AI to analyze transthoracic cardiac ultrasound images and automatically estimate the left ventricular ejection fraction. This helps clinicians in cardiac evaluations by providing a consistent and efficient measurement of heart function, aiding diagnosis and treatment decisions.

FDA #
K200621
Product Code
QIH

Caption Guidance is an AI-powered software that assists healthcare professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance similar to an expert sonographer, helping to capture standard echocardiographic views accurately and efficiently during 2D transthoracic echocardiography.

FDA #
K200755
Product Code
QJU
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