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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K113337
Model VERSION 5.0
Device Name VISIA DYNAMIC REVIEW
Original Applicant
MEVIS MEDICAL SOLUTIONS AG
n27 w24075 paul court
suite 100
pewaukee,  WI  53072
Original Contact thomas e tynes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/14/2011
Decision Date 12/30/2011
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 Yes
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