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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K103506
Device Name 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
Applicant
Imris, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact THOMAS M TASKERIS
Correspondent
Imris, Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact THOMAS M TASKERIS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/29/2010
Decision Date 02/02/2011
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
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