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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 (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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