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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 K080062
Device Name OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44087
Applicant Contact DOUG THISTLEWAITE
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG,  OH  44087
Correspondent Contact DOUG THISTLEWAITE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/09/2008
Decision Date 02/11/2008
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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