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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
Model FDR200
Device Name FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
Original Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford,  CT  06902 6300
Original Contact katherine y choi
Regulation Number892.1740
Classification Product Code
IZF  
Date Received05/21/2012
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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