Solid State X-ray Imager (flat Panel/digital Imager)

Vieworks Co., Ltd.

The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Vivix-s Vw.

Pre-market Notification Details

Device IDK200418
510k NumberK200418
Device Name:VIVIX-S VW
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Anyang-si,  KR 14055
ContactJordin Kim
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-20
Decision Date2020-03-18

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