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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
Applicant
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902 -6300
Applicant Contact DEBBIE PEACOCK
Correspondent
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902 -6300
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.1680
Classification Product Code
KPR  
Date Received08/13/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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