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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 Rd.
Rockville,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
Imris, Inc.
16809 Briardale Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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