Shear Wave Quantificational Ultrasound Diagnostic System

System, Imaging, Pulsed Echo, Ultrasonic

Wuxi Hisky Medical Technologies Co., Ltd.

The following data is part of a premarket notification filed by Wuxi Hisky Medical Technologies Co., Ltd. with the FDA for Shear Wave Quantificational Ultrasound Diagnostic System.

Pre-market Notification Details

Device IDK200136
510k NumberK200136
Device Name:Shear Wave Quantificational Ultrasound Diagnostic System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Wuxi Hisky Medical Technologies Co., Ltd. B401, 530 Plaza, University Science Park, Taihu International Science & Tech. Wuxi,  CN 214135
ContactJinhua Shao
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing,  CN 102401
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-03-17

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