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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 K200136
Device Name Shear Wave Quantificational Ultrasound Diagnostic System
Applicant
Wuxi Hisky Medical Technologies Co., Ltd.
B401, 530 Plz., University Science Park,
Taihu International Science & Tech.
Wuxi,  CN 214135
Applicant Contact Jinhua Shao
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
5-402, Bldg. #27, # 56, Liangxiang E. Rd.,
Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received01/21/2020
Decision Date 03/17/2020
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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