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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K021314
Device Name SCEPTRE-VS
Original Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg,  OH  44087
Original Contact robert h mccarthy
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/25/2002
Decision Date 07/02/2002
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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