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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 K061281
Device Name INSIGHT HEAD COIL
Applicant
Insight Neuroimaging Systems, LLC
11 Canterbury St.
Worchester,  MA  01610
Applicant Contact PATRICIA A MILBANK
Correspondent
Insight Neuroimaging Systems, LLC
11 Canterbury St.
Worchester,  MA  01610
Correspondent Contact PATRICIA A MILBANK
Regulation Number892.1000
Classification Product Code
MOS  
Date Received05/08/2006
Decision Date 06/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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