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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 K083539
Device Name INFANT CARDIAC ARRAY
Applicant
Advanced Imaging Research, Inc.
4700 Lakeside Ave.
Suite 400
Cleveland,  OH  44114
Applicant Contact RAVI SRINIVASAN
Correspondent
Advanced Imaging Research, Inc.
4700 Lakeside Ave.
Suite 400
Cleveland,  OH  44114
Correspondent Contact RAVI SRINIVASAN
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/28/2008
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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