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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Accessories, Image Post-Processing For Color Enhancement
510(k) Number K140149
FOIA Releasable 510(k) K140149
Device Name EPX-4440HD DIGITAL VIDEO PROCESSOR
Applicant
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Applicant Contact MARY K MOORE
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Correspondent Contact MARY K MOORE
Regulation Number876.1500
Classification Product Code
PEA  
Subsequent Product Codes
FET   GCT  
Date Received01/22/2014
Decision Date 08/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02005393
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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