Paragon XHD Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Shenzhen Wisonic Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Wisonic Medical Technology Co., Ltd. with the FDA for Paragon Xhd Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK191347
510k NumberK191347
Device Name:Paragon XHD Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Wisonic Medical Technology Co., Ltd. 1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan Shenzhen,  CN 518055
ContactJiang Xiaosan
CorrespondentJiang Xiaosan
Shenzhen Wisonic Medical Technology Co., Ltd. 1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan Shenzhen,  CN 518055
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-20
Decision Date2020-02-07

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