Navi E/Navi S/Navi X 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 Navi E/navi S/navi X Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK180461
510k NumberK180461
Device Name:Navi E/Navi S/Navi X Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Wisonic Medical Technology Co., Ltd. 1st And 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 And 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-20
Decision Date2018-05-09
Summary:summary

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