The following data is part of a premarket notification filed by Irm Inc with the FDA for I-rapha Solution.
| Device ID | K201296 |
| 510k Number | K201296 |
| Device Name: | I-Rapha Solution |
| Classification | System, Image Processing, Radiological |
| Applicant | IRM Inc 4th-D, Myung-Woo Bldg, 169, Yeoksam-ro Gangnam-gu, KR 06247 |
| Contact | Kim Yun Ik |
| Correspondent | Kim Yun Ik IRM Inc. 4th-D, Myung-Woo Bldg, 169, Yeoksam-ro Gangnam-gu, KR 06247 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2020-07-09 |