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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 K061916
Device Name NEURO II-SE, MODELS OR-MB-DR AND OR-DR
Original Applicant
IMRIS, INC.
16809 briardale road
rockville,  MD  20855
Original Contact thomas m tsakeris
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/06/2006
Decision Date 08/11/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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