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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K113341
Device Name GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
Original Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg,  OH  44087
Original Contact doug thistlethwaite
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/14/2011
Decision Date 05/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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