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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
Device Name SYNAPSE 3D BASE TOOLS
Applicant
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact DEBBIE PEACOCK
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/06/2012
Decision Date 04/06/2012
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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