The following data is part of a premarket notification filed by Radisen Co., Ltd with the FDA for Axir-cx.
| Device ID | K213520 |
| 510k Number | K213520 |
| Device Name: | AXIR-CX |
| Classification | System, Image Processing, Radiological |
| Applicant | Radisen Co., Ltd B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu Anyang-si, KR 14058 |
| Contact | John Lim |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St. Suite 610 Houston, TX 77054 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-03 |
| Decision Date | 2022-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800099500076 | K213520 | 000 |