INNOLUX RIC

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

INNOLUX CORPORATION

The following data is part of a premarket notification filed by Innolux Corporation with the FDA for Innolux Ric.

Pre-market Notification Details

Device IDK162344
510k NumberK162344
Device Name:INNOLUX RIC
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant INNOLUX CORPORATION No. 3, Sec. 1, Huansi Rd. Tainan City, Southern Taiwan Science Par,  TW 74147
ContactAndy Kuo
CorrespondentAndy Kuo
INNOLUX CORPORATION No. 3, Sec. 1, Huansi Rd. Tainan City, Southern Taiwan Science Par,  TW 74147
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-22
Decision Date2016-12-20

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