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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.

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging Inc.
510k7/1/2025

StrokeSENS ASPECTS Software Application by Circle Cardiovascular Imaging Inc. is a computer-assisted diagnostic tool designed to assist clinicians in evaluating lesions suspicious for cancer, potentially improving diagnostic accuracy in radiology.

FDA #
K250221
Product Code
POK
Task:ClassificationTarget Condition:Lesion

Myocardial Strain Software Application

Circle Cardiovascular Imaging
510k12/7/2023

The Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.

FDA #
K232661
Product Code
LLZ
Modality:MRITask:ClassificationBody Region:Cardiac
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