The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray M18 (model: Vmx-p400).
| Device ID | K213462 |
| 510k Number | K213462 |
| Device Name: | EzRay M18 (Model: VMX-P400) |
| Classification | System, X-ray, Mobile |
| Applicant | Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si, KR 18449 |
| Contact | Daniel Kim |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St., Ste. 200-Vlll Houston, TX 77054 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-27 |
| Decision Date | 2022-02-11 |