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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointesinal Lesion Software Detection System
510(k) Number K230751
Device Name EW10-EC02 Endoscopy Support Program
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Healthcare Americas Corporation
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number876.1520
Classification Product Code
QNP  
Date Received03/17/2023
Decision Date 12/15/2023
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
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