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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K120361
Model VERISON 3.0
Device Name SYNAPSE 3D BASE TOOLS
Original Applicant
FUJIFILM MEDICAL SYSTEMS USA, INC.
419 west avenue
stamford,  CT  06902
Original Contact debbie peacock
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/06/2012
Decision Date 04/06/2012
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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