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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 K063513
Device Name ECHELON MR-RCC-150 CARDIAC COIL
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44080
Applicant Contact DOUGLAS J THISTLEWAITE
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44080
Correspondent Contact DOUGLAS J THISTLEWAITE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/21/2006
Decision Date 12/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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