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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 K242511
Device Name V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
Applicant
Samsung Medison Co. , Ltd.
3366, Hanseo-Ro, Nam-Myeon
Hongcheon-Gun,  KR 25108
Applicant Contact Jee Young Ju
Correspondent
Samsung Medison Co. , Ltd.
3366, Hanseo-Ro, Nam-Myeon
Hongcheon-Gun,  KR 25108
Correspondent Contact So-Yeon Jang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received08/23/2024
Decision Date 12/10/2024
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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