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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 K072279
Device Name MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Original Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg,  OH  44087
Original Contact doug thistlethwaite
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/16/2007
Decision Date 09/21/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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