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.

The Rist Radial Access Catheter family consists of single lumen catheters designed to provide access to peripheral, coronary, and neuro vasculature. These catheters assist clinicians in delivering interventional devices and diagnostic agents, particularly in neurovascular procedures, improving access with features like hydrophilic coatings and radiopaque markers for better visualization under fluoroscopy.

FDA #
K241388
Product Code

The Natus BrainWatch System is a portable EEG monitoring device that records and visually presents EEG signals to assist trained medical personnel in neurological diagnosis for patients aged 2 years and older. It features a disposable headband with integrated electrodes, wireless connectivity, and cloud storage, enabling rapid and convenient EEG monitoring in healthcare settings.

FDA #
K242930
Product Code
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