The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Xmaruview V1 (xmaru Chiroview, Xmaru Podview).
| Device ID | K190866 |
| 510k Number | K190866 |
| Device Name: | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) |
| Classification | System, Image Processing, Radiological |
| Applicant | Rayence Co., Ltd 14, Samsung 1-ro, 1-gil 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 | 2019-04-03 |
| Decision Date | 2019-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018600610 | K190866 | 000 |
| 08800018600603 | K190866 | 000 |
| 08800018600597 | K190866 | 000 |
| 08800018600580 | K190866 | 000 |