The following data is part of a premarket notification filed by Innocare Optoelectronics Corp. with the FDA for Yushan X-ray Flat Panel Detector.
| Device ID | K191939 |
| 510k Number | K191939 |
| Device Name: | Yushan X-Ray Flat Panel Detector |
| Classification | Solid 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 |
| Contact | Yumei Cheng |
| Correspondent | Yumei 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 Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-19 |
| Decision Date | 2019-08-29 |