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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K261119
Device Name NorthStar Mapping System (MAP01 or MAP01-01)
Applicant
Imricor Medical Systems, Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Applicant Contact Oksana Alswager
Correspondent
Imricor Medical Systems, Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Correspondent Contact Oksana Alswager
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/03/2026
Decision Date 06/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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