VIVIX-S 1417N

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 1417n.

Pre-market Notification Details

Device IDK163703
510k NumberK163703
Device Name:VIVIX-S 1417N
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant VIEWORKS CO., LTD. (GWANYANG-DONG) 41-3, BURIM-RO 170BEON-GIL, Anyang-si,  KR 431-060
ContactJordin Kim
CorrespondentPriscilla Chung
LK CONSULTING GROUP USA INC. 800 ROOSEVELT STE 417 Irvine,  CA  92620
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-29
Decision Date2017-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809394330234 K163703 000
08809394330227 K163703 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.