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.

PRAEVAorta®2 by Nurea is an automated software tool designed to assist clinicians by processing radiological images of the aorta. It helps in analyzing medical images to provide more accurate and efficient assessments, supporting diagnosis and treatment planning related to aortic conditions.

FDA #
K243859
Product Code
QIH

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.

FDA #
K250754
Product Code
QIH

TeraRecon Aorta.CT is a software that automatically segments and labels key anatomical landmarks of the aorta from contrast CT Angiography scans. It helps trained medical professionals by providing 3D visualizations and measurements to assist in patient management and procedure planning, without altering the original scan data or providing diagnosis.

FDA #
K243158
Product Code
QIH

BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.

FDA #
K242203
Product Code
QIH

uAI Portal is a medical imaging software system developed by Shanghai United Imaging Intelligence Co., Ltd. It provides tools to view, manipulate, and evaluate CT angiography studies focused on vascular structures within various anatomical regions including lower extremities, head and neck, coronary arteries, pulmonary arteries, and aorta. The software uses AI-based segmentation algorithms to help clinicians analyze vessel structures accurately and efficiently, making it easier to interpret complex vascular imaging data and facilitating clinical decision-making.

FDA #
K240411
Product Code
QIH
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