VIVIX-S 1717V

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 1717v.

Pre-market Notification Details

Device IDK181003
510k NumberK181003
Device Name:VIVIX-S 1717V
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Vieworks Co., Ltd. (Gwanyang-dong) 41-3, Burim-ro 170beon-gil, Dongan-gu Anyang-si,  KR 431-060
ContactJordin Kim
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 690 Roosevelt Irvine,  CA  92620
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-16
Decision Date2018-05-15
Summary:summary

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