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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 K243702
Device Name V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon,
Hongcheon-Gun,  KR 25108
Applicant Contact Yujin Kim
Correspondent
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon,
Hongcheon-Gun,  KR 25108
Correspondent Contact Yujin Kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ   QIH  
Date Received11/29/2024
Decision Date 02/12/2025
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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