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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K113145
Device Name ECHELON OVAL MRI SYSTEM
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
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received10/25/2011
Decision Date 05/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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