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.
510k4/24/2025
Lung AI (LAI001) is a software tool that assists healthcare professionals by analyzing lung ultrasound scans to detect signs of consolidation/atelectasis and pleural effusion. It highlights regions of interest on ultrasound cine clips to help clinicians identify potential lung issues, improving review efficiency but not replacing clinical judgment or other diagnostic tests. It supports physicians particularly in emergency departments during point-of-care lung ultrasounds.
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