The following data is part of a premarket notification filed by Astel Inc. with the FDA for Rfa-1717dig, Rfa-1717dic.
| Device ID | K212051 |
| 510k Number | K212051 |
| Device Name: | RFA-1717DIG, RFA-1717DIC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ASTEL Inc. 26-79, Gajeongbuk-ro, Yuseong-gu Daejeon, KR 34113 |
| Contact | Yonghwan Jeon |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-08-25 |