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 xvision Spine System by Augmedics Ltd. is an augmented reality-based surgical navigation system designed to aid surgeons in precisely locating anatomical structures during open or percutaneous spine procedures. It combines preoperative CT or intraoperative X-ray imaging with a headset that overlays virtual 3D navigation information directly onto the patient's anatomy in real-time, enhancing surgical accuracy and safety for spine operations such as pedicle screw placement and other spinal trajectories.

FDA #
K241481
Product Code
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