Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

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 Fw (model: Fxrd-2530faw, Fxrd-3643faw, Fxrd-4343faw).

Pre-market Notification Details

Device IDK221512
510k NumberK221512
Device Name:Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Dongan-gu Anyang-si,  KR 14055
ContactKevin Oh
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine,  CA  92612
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-24
Decision Date2022-07-20

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