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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 K142521
Device Name Synapse 3D Liver and Kidney Analysis
Applicant
FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Applicant Contact JYH-SHYAN LIN
Correspondent
FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Correspondent Contact JYH-SHYAN LIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/08/2014
Decision Date 12/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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