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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 K163232
Device Name Vitrea View
Applicant
Vital Images, Inc
5850 Opus Parkway
Suite 300
minnetonka,  MN  55343
Applicant Contact fei li
Correspondent
Vital Images, Inc
5850 Opus Parkway
Suite 300
minnetonka,  MN  55343
Correspondent Contact fei li
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/17/2016
Decision Date 07/21/2017
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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