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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 K252018
Device Name HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon,
Hongcheon-Gun,  KR 25108
Applicant Contact So-Yeon Jang
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   LLZ   QIH  
Date Received06/30/2025
Decision Date 01/05/2026
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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