The following data is part of a premarket notification filed by Rayence Co., Ltd. with the FDA for 1012wcc, 1012wgc.
| Device ID | K162518 |
| 510k Number | K162518 |
| Device Name: | 1012WCC, 1012WGC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | RAYENCE CO., LTD. 14, SAMSUNG 1-RO, 1-GIL Hwaseong-si, KR 445-170 |
| Contact | Kevin Kim |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2016-10-06 |
| Summary: | summary |