FDA Radiology AI Devices

The Zeta Cranial Navigation System is a stereotaxic image guidance system designed to help neurosurgeons spatially position and orient surgical instruments during cranial surgery. It uses 3D preoperative CT or MRI scans to assist in real-time navigation without requiring rigid fixation of the patient. This system enhances the precision of neurosurgical procedures by providing visual guidance based on medical imaging data.

Alignment System Cranial by Brainlab AG is a surgical navigation system designed to assist surgeons during cranial stereotactic procedures such as biopsies of intracranial lesions and placement of stereo-electroencephalography electrodes. It integrates optical tracking with advanced software and hardware to precisely guide surgical instruments, improving accuracy and safety. The system includes artificial intelligence features that aid in patient registration processes by detecting anatomical landmarks, enhancing surgical planning and execution.

The Cranial Navigation and Cranial EM System by Brainlab AG is an image-guided surgical navigation system designed to assist surgeons during cranial and craniofacial procedures. It uses imaging data like CT, MR, X-Ray, and ultrasound to track surgical instruments relative to patient anatomy. The system integrates artificial intelligence via machine learning algorithms to detect brain abnormalities and anatomical landmarks in MR images to enhance registration accuracy and view centering, helping surgeons perform more precise navigation in complex brain surgeries.

Brainlab Elements Trajectory Planning (2.6) is a software designed to help neurosurgeons plan the best paths for surgical instruments during cranial procedures, such as electrode placements or biopsies. It uses anatomical images from scans to plan and guide minimally invasive or open surgeries, enhancing precision and improving patient outcomes.

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a stereotaxic image-guided navigation system that assists surgeons in performing precise cranial surgery. It provides real-time tracking of instruments, image registration with preoperative scans, and step-by-step guidance for biopsies and ventricular catheter placement, improving surgical accuracy and safety.