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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 K112439
Device Name SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
stamford,  CT  06902 -6300
Applicant Contact jyh-shyan lin
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
stamford,  CT  06902 -6300
Correspondent Contact jyh-shyan lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/24/2011
Decision Date 10/17/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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