The following data is part of a premarket notification filed by Radisen Co., Ltd with the FDA for Pedra-1417mc, Pedra-1417mg, Pedra-1417fc, Pedra-1417fg.
| Device ID | K221144 |
| 510k Number | K221144 |
| Device Name: | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Radisen Co., Ltd 14F, 128, Gongduk B/D, 11, Saechang-ro, Mapo-gu Seoul, KR 04168 |
| Contact | John Lim |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St. Suite 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 | 2022-04-20 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800099500090 | K221144 | 000 |
| 08800099500083 | K221144 | 000 |
| 08800099500045 | K221144 | 000 |
| 08800099500038 | K221144 | 000 |