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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, Tomographic
510(k) Number K121499
Device Name FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
Applicant
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact KATHERINE Y CHOI
Correspondent
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact KATHERINE Y CHOI
Regulation Number892.1740
Classification Product Code
IZF  
Date Received05/21/2012
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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