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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 K110186
Device Name SYNAPSE 3D LIVER ANALYSIS
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Applicant Contact KIMERLY A SHARP
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Correspondent Contact KIMERLY A SHARP
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/21/2011
Decision Date 04/07/2011
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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