FDA Radiology AI Devices

The Precision AI Surgical Planning System (PAI-SPS) is an AI-enhanced medical device that assists surgeons in planning and performing shoulder joint replacements. It uses CT scan images to create a 3D model of the patient's shoulder, helps surgeons simulate and optimize implant positioning, and can produce custom surgical guides for use during the procedure. This system helps improve surgical accuracy and outcomes for shoulder arthroplasty patients.

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.

The Arthrex Virtual Implant Positioning (VIP) System Software is a medical software tool designed to assist surgeons in preoperative planning and precise placement of implants for total shoulder replacement. It processes and displays CT imaging data to help plan and adjust implant positioning, enhancing surgical accuracy and patient outcomes.

The Precision AI Surgical Planning System (PAI-SPS) is a software and hardware system designed to assist surgeons in preoperative planning and intraoperative guidance for shoulder replacement surgeries. It creates a 3D model of the patient's shoulder joint from CT scans, allowing surgeons to visualize and plan implant placement precisely. Custom surgical guides are also produced to help accurately position shoulder implant components during surgery, enhancing surgical outcomes.