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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 K121213
Device Name VITREAADVANCED
Original Applicant
VITAL IMAGES, INC.
5850 opus parkway,
suite 300
minnetonka,  MN  55343 4414
Original Contact daniel biank
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/20/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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