NorthStar Mapping System
Imricor Medical SystemsThe NorthStar Mapping System is a 3D mapping and navigation tool designed to assist cardiovascular interventional procedures using MRI. It provides clinicians with a real-time 3D environment showing MRI images, anatomical representations, device locations, and electrophysiological data to help plan and guide cardiac interventions safely and effectively.
Intended Use
The NorthStar Mapping System is intended to aid interventional Cardiovascular Magnetic Resonance Imaging (iCMRI) procedures, including electrophysiology procedures, by providing a 3D environment in which MR images, devices, and procedure-related data are displayed.
Technology
The system consists of a computer and application software that communicates with a compatible MR scanner and an EP Recorder/Stimulator system during electrophysiological procedures. It provides real-time MRI images, 3D anatomical representations, device tracking, electroanatomical maps, and ablation point visualization, enabling procedure planning, guidance, and assessment.
Performance
Software verification and validation testing demonstrated that the NorthStar Mapping System performs as intended. Human factors testing confirmed safe use. All issues from testing were resolved, supporting substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
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