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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 K261272
Device Name ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
Applicant
Esonic Technology (Wuhan) Co., Ltd.
Floor 7, Bldg. B1, Block B, Phase Ii, High-Tech Medical Devi
Wuhan,  CN 430000
Applicant Contact Souquet Jacques
Correspondent
Esonic Technology (Wuhan) Co., Ltd.
Floor 7, Bldg. B1, Block B, Phase Ii, High-Tech Medical Devi
Wuhan,  CN 430000
Correspondent Contact Guo Dongyun
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/17/2026
Decision Date 07/23/2026
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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