K213462 is an FDA 510(k) clearance for the EzRay M18 (Model: VMX-P400). This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 11, 2022, 107 days after receiving the submission on October 27, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K213462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2021 |
| Decision Date | February 11, 2022 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |