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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 K121997
Device Name IMRIS ONCOLOGY PACKAGE
Applicant
IMRIS, INC.
100-1370 sony place
winnipeg, mb, 
Contact sanjay shah
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received07/09/2012
Decision Date 08/10/2012
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
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