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.

Imbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.

FDA #
K241847
Product Code
QIH

Imbio RV/LV Software is an AI-powered medical imaging tool that automatically measures the diameters of the right and left ventricles of the heart from CT pulmonary angiography scans. It provides annotated images and reports to assist physicians in evaluating heart function, supporting clinical decision-making as part of cardiac assessment workflows.

FDA #
K203256
Product Code
QIH
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