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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 K181247
Device Name Vitrea CT Brain Perfusion
Applicant
Vital Images, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343 -4414
Applicant Contact Susan Atwood
Correspondent
Vital Images, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343 -4414
Correspondent Contact Susan Atwood
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/10/2018
Decision Date 11/20/2018
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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