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 O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.

FDA #
K240465
Product Code
OWB
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