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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 K254099
Device Name EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon
Hongcheon-Gun,  KR 25108
Applicant Contact Yoojung Choi
Correspondent
Samsung Medison Co., Ltd.
3366, Hanseo-Ro, Nam-Myeon
Hongcheon-Gun,  KR 25108
Correspondent Contact Yoojung Choi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received12/19/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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