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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K150104
Device Name Vitrea CT Myocardial Perfusion
Applicant
Vital Images, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343 -4414
Applicant Contact Parthiv Shah
Correspondent
Vital Images, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343 -4414
Correspondent Contact Parthiv Shah
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received01/20/2015
Decision Date 04/17/2015
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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