Yushan X-Ray Flat Panel Detector With DROC

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

InnoCare Optoelectronics Corp.

The following data is part of a premarket notification filed by Innocare Optoelectronics Corp. with the FDA for Yushan X-ray Flat Panel Detector With Droc.

Pre-market Notification Details

Device IDK201528
510k NumberK201528
Device Name:Yushan X-Ray Flat Panel Detector With DROC
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744, Taiwan (R.O.C.) Tainan City,  TW 744
ContactYumei Cheng
CorrespondentYumei Cheng
InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744, Taiwan (R.O.C.) Tainan City,  TW 744
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-10-11

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