Imricor Medical Systems · Class II · Cleared Jan 28, 2026
| K-number | K252164 |
| Device name | NorthStar Mapping System |
| Applicant | Imricor Medical Systems |
| Product code | DQK |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The NorthStar Mapping System is a 3D mapping and navigation software system designed to aid interventional cardiovascular magnetic resonance imaging (iCMRI) procedures, including electrophysiology procedures. It displays real-time MR images, 3D anatomical representations, device locations, electroanatomical maps, and ablation points in a single 3D environment to guide procedure planning and assessment.
NorthStar integrates MRI imaging with real-time device tracking using active tracking coils, operates from the control room, displays electroanatomical mapping capabilities, and synchronizes with MR imaging. Unlike the predicate CARTO 3 EP system, NorthStar uniquely incorporates MRI integration and real-time localization of intracardiac devices within the MR environment.
Not stated in this summary.
NorthStar is substantially equivalent to the CARTO 3 EP Navigation System (K231207) because both are Class II programmable diagnostic computers with equivalent device classifications, similar indications for use in interventional cardiac procedures, and equivalent real-time localization and electroanatomical mapping capabilities. A reference device (EndoScout Tracking System) supports the additional MRI-specific tracking technology. Software verification, validation, and human factors testing confirmed the device performs as intended.
View the full FDA submission: accessdata.fda.gov