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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 K113365
Device Name INFANT ARRAY
Applicant
Advanced Imaging Research Dba Sree Medical Systems
P.O. Box 603220
Cleveland,  OH  44103
Applicant Contact RAVI SPRINIVASAN
Correspondent
Advanced Imaging Research Dba Sree Medical Systems
P.O. Box 603220
Cleveland,  OH  44103
Correspondent Contact RAVI SPRINIVASAN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/15/2011
Decision Date 03/29/2012
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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