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.

LiverSmart is a software that automatically analyzes MRI images of the liver to measure both liver iron concentration and liver fat content. It processes images according to established protocols and generates a comprehensive report that assists clinicians in diagnosing and monitoring liver conditions such as iron overload and fatty liver disease, supporting treatment decisions and research.

FDA #
K213776
Product Code
PCS

FerriSmart is a medical software that automatically analyzes MRI scans of the liver to measure iron concentration. This helps doctors diagnose and monitor patients with iron overload diseases, such as thalassemia or sickle cell disease, making treatment decisions more accurate and timely.

FDA #
K182218
Product Code
PCS
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