The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for Xmaru View V1 And Xmaru Pacs, Medical Image Processing Software.
| Device ID | K160579 |
| 510k Number | K160579 |
| Device Name: | Xmaru View V1 And Xmaru PACS, Medical Image Processing Software |
| Classification | System, Image Processing, Radiological |
| Applicant | RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL Hwaseong-si, KR 445-170 |
| 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 | 2016-03-01 |
| Decision Date | 2016-04-08 |
| Summary: | summary |