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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 Spectroscopic
510(k) Number K093044
Device Name OASIS 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
LNI  
Date Received09/30/2009
Decision Date 03/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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