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 Materialise Shoulder System is a patient-specific medical device designed to assist surgeons in preoperative planning and intraoperative positioning of shoulder replacement components. It includes the SurgiCase Shoulder Planner software, which utilizes CT imaging to generate detailed 3D pre-surgical plans. Based on these plans, patient-specific guides and models are created to help precisely position implants during surgery, improving surgical accuracy and outcomes for total and reverse shoulder arthroplasty.

FDA #
K242813
Product Code
QHE
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