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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K182130
Device Name iSchemaView RAPID
Applicant
Ischemaview, Inc.
201 Marshall St., Suite 101
Redwood City,  CO  94063
Applicant Contact Jim Rosa
Correspondent
Ischemaview, Inc.
433 Park Point Dr., Suite 220
Golden,  CO  80401
Correspondent Contact Jim Rosa
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/06/2018
Decision Date 12/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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