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.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is a system that combines 3D surgical planning software with patient-specific physical guides and models to assist surgeons in facial bone surgeries. It helps surgeons visualize patient anatomy, plan interventions, and accurately carry out surgeries by guiding instruments and bone cutting based on a customized surgical plan created from medical images.

FDA #
K243637
Product Code
DZJ
Panel
Dental
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