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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 K201094
Device Name iMap 3D Mapping & Navigation System (iMap System)
Applicant
CardioNXT, Inc.
12011 Tejon Street, Suite 700
Westminster,  CO  80234
Applicant Contact Kirk Mackin
Correspondent
CardioNXT, Inc.
12011 Tejon Street, Suite 700
Westminster,  CO  80234
Correspondent Contact Jerome R Edwards
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/24/2020
Decision Date 08/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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