The following data is part of a premarket notification filed by Rayence Co., Ltd. with the FDA for 1717scv, 1717sgv.
| Device ID | K201796 |
| 510k Number | K201796 |
| Device Name: | 1717SCV, 1717SGV |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Rayence Co., Ltd. 14, Samsung 1-ro 1-gil Hwaseong-si, KP |
| Contact | Kee Dock Kim |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste 200, V111 Houston, TX 77054 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018600634 | K201796 | 000 |
| 08800018600627 | K201796 | 000 |