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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 K083086
Device Name ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44087
Applicant Contact DOUG THISTLETHWAITE
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44087
Correspondent Contact DOUG THISTLETHWAITE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/16/2008
Decision Date 12/05/2008
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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