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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 K242496
Device Name Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
Applicant
Eieling Technology (Shenzhen) Limited
Rm.610, Bldg. E, Qihang Innovation Development Park # 1008
Songhai Rd., Yangguang Community, Xili St. Nanshan District
Shenzhen,  CN 518052
Applicant Contact Salon Chen
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11, # 23 Jinqu Rd., Wanjiang District
Dongguan,  CN 523069
Correspondent Contact Salon Chen
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/22/2024
Decision Date 11/19/2024
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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