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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 Echo, Ultrasonic
510(k) Number K233401
Device Name Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
Applicant
Eieling Technology Limited
Rm.529, 5/F, Core Bldg. 5w
Hong Kong Science Park
Hong Kong,  CN
Applicant Contact Yangmin Lin
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11, # 23 Jinqu Rd., Wanjiang
District, Dongguan City
Dongguan,  CN 523000
Correspondent Contact Salon Chen
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received10/04/2023
Decision Date 02/12/2024
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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