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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 K172855
Device Name Vitrea Advanced Visualization, Version 7.6
Applicant
Vital Images, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343
Applicant Contact Katie Ryan
Correspondent
Vital Images, Inc.
5850 Opus Pkwy., Suite 300
Minnetonka,  MN  55343
Correspondent Contact Katie Ryan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/20/2017
Decision Date 10/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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