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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K250883
Device Name ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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 West Park Drive
Westborough,  MA  01581
Correspondent Contact Brenda Geary
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
ODG  
Date Received03/24/2025
Decision Date 09/18/2025
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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