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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, stationary
510(k) Number K122454
Device Name FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
Original Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford,  CT  06902 6300
Original Contact debbie peacock
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/13/2012
Decision Date 11/20/2012
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
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