VIVIX-S

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.

Pre-market Notification Details

Device IDK120020
510k NumberK120020
Device Name:VIVIX-S
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant VIEWORKS CO., LTD. 951 STARBUCK ST UNIT J Fullerton,  CA  92833
ContactPriscilla Chung
CorrespondentPriscilla Chung
VIEWORKS CO., LTD. 951 STARBUCK ST UNIT J Fullerton,  CA  92833
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-05-04
Summary:summary

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