NorthStar Mapping System (MAP01 or MAP01-01)
Imricor Medical Systems, Inc.The NorthStar Mapping System by Imricor Medical Systems, Inc. is a medical device designed to aid cardiovascular procedures through real-time magnetic resonance images and 3D anatomical maps, supporting electrophysiology procedures by displaying anatomical and device information in a comprehensive environment to assist clinicians in diagnosis and treatment planning.
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 electrophysiology recording/stimulation system, providing real-time MR images, 3D anatomical representations, interventional device locations, electroanatomical maps, and therapy delivery information within a 3D environment.
Performance
The submission is supported by a technical analysis of real-world data demonstrating safe MR-based imaging and visualization in pediatric patients, with risk analysis confirming no new hazards or changes in safety and effectiveness, supported by estimated residual evaluations within pediatric limits.
Predicate Devices
No predicate devices specified
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