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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 K071099
Device Name NEURO II-SE, MODELS: OR-DR-OR, OR-MB
Applicant
IMRIS, INC.
16809 BRIARDALE ROAD
ROCKVILLE,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
IMRIS, INC.
16809 BRIARDALE ROAD
ROCKVILLE,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/19/2007
Decision Date 05/22/2007
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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