The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for 1717fcc.
| Device ID | K210985 |
| 510k Number | K210985 |
| Device Name: | 1717FCC |
| 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 7505 Fannin St. Ste 610 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 | 2021-04-01 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018600887 | K210985 | 000 |