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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 K120679
Device Name SYNAPSE 3D NODULE ANALYSIS
Original Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford,  CT  06902 -6300
Original Contact jyh-shyan lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/06/2012
Decision Date 06/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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