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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 K102889
Device Name HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44087
Applicant Contact DOUGH THISTLETHWAITE
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44087
Correspondent Contact DOUGH THISTLETHWAITE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/30/2010
Decision Date 12/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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