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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K171207
Device Name FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
Applicant
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Applicant Contact Jeffrey Wan
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
ITX   IYO  
Date Received04/25/2017
Decision Date 01/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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