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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K243502
Device Name EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
Applicant
Olympus Medical Systems Corporation
2951 Ishikawa-Cho
Hachioji-Shi,  JP 92-8507
Applicant Contact Toshio Nakamura
Correspondent
Olympus Surgical Technologies of the Americas
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Wendy Perreault
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   ODG  
Date Received11/12/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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