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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
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Applicant Contact JYH-SHYAN LIN
Correspondent
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Correspondent 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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