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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 K122578
Device Name VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
Original Applicant
VITAL IMAGES, INC.
5850 opus pkwy ste 300
minnetonka,  MN  55343
Original Contact ian nemerov
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/23/2012
Decision Date 02/25/2013
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
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