The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Digital Flat Panel X-ray Detector / 1012wca.
| Device ID | K123345 |
| 510k Number | K123345 |
| Device Name: | DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | RAYENCE CO., LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim RAYENCE CO., LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-03-12 |
| Summary: | summary |