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.
|Device Name:||Yushan X-Ray Flat Panel Detector With DROC|
|Classification||Solid State X-ray Imager (flat Panel/digital Imager)|
|Applicant||InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist. Tainan City, TW 741|
InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist. Tainan City, TW 741
|CFR Regulation Number||892.1680 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|