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.
510k12/6/2024
The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.
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