The following data is part of a premarket notification filed by Rayence Co.,ltd with the FDA for Clearon Mobile.
| Device ID | K183478 |
| 510k Number | K183478 |
| Device Name: | ClearON Mobile |
| Classification | System, Image Processing, Radiological |
| Applicant | Rayence Co.,Ltd 14, Samsung 1-ro, 1gil Hwaseong-si, KR 18449 |
| Contact | Kevin Kim |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-03-01 |
| Summary: | summary |