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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 Parkway, Suite 300
Minnetonka,  MN  55343 -4414
Applicant Contact Susan Atwood
Correspondent
Vital Images, Inc.
5850 Opus Parkway, 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
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