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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 K101686
Device Name FDR IMAGE STITCHING OPTION
Applicant
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact DEBBIE PEACOCK
Correspondent
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/16/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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