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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 K122026
Model VERISON 4.0
Device Name PRISM ACQUIRE PRISM PROCESS PRISM VIEW
Original Applicant
PRISM CLINICAL IMAGING, INC.
890 elm grove rd., suite 215
elm grove,  WI  53122
Original Contact james l reuss
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received07/11/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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