The following data is part of a premarket notification filed by Rayence Co., Ltd with the FDA for 2430mca With Xmaru W.
| Device ID | K202902 |
| 510k Number | K202902 |
| Device Name: | 2430MCA With Xmaru W |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | Rayence Co., Ltd 14, Samsung 1-ro 1-gil Hwaseong-si, KR |
| Contact | Kee Dock Kim |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste. 200 Houston, TX 77054 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800018600726 | K202902 | 000 |