Cleared Traditional

EzRay M18 (Model: VMX-P400)

K213462 · VATECH Co., Ltd. · Radiology
Feb 2022
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K213462 is an FDA 510(k) clearance for the EzRay M18 (Model: VMX-P400), 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 review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K213462 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

Similar Devices — IZL System, X-ray, Mobile

All 233
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
K253185 · Carestream Health · Mar 2026
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
K253244 · Poskom Co., Ltd. · Feb 2026
Airbile-100
K250976 · Poskom Co., Ltd. · Dec 2025
Mobile X-ray unit (!M1)
K251710 · Solutions For Tomorrow AB · Oct 2025
BONX805
K243864 · Bontech Co., Ltd. · Sep 2025
PROMO
K251443 · DRGEM Corporation · Aug 2025