FDA 510(k)

EzRay M18 (Model: VMX-P400)

K-Number: K213462 · 2022-02-11

Decision Date2022-02-11

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EzRay M18 (Model: VMX-P400) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under approval number K213462. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EzRay M18 (Model: VMX-P400)?

EzRay M18 (Model: VMX-P400) is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K213462.

When was EzRay M18 (Model: VMX-P400) approved by the FDA?

EzRay M18 (Model: VMX-P400) received FDA 510(k) clearance on 2022-02-11, under approval number K213462.

What company makes EzRay M18 (Model: VMX-P400)?

EzRay M18 (Model: VMX-P400) is manufactured by VATECH Co., Ltd..

What is the FDA product code for EzRay M18 (Model: VMX-P400)?

The FDA product code for EzRay M18 (Model: VMX-P400) is IZL.

Other Devices by VATECH Co., Ltd.

K160882PaX-i3D Green Premium (Model: PCT-90LH) K162660Green Smart (Model: PHT-35LHS) K161063EzRay Air (Model VEX-P300) K170066Green16/Green18 (Model: PHT-65LHS) K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight K163705EzRay Air W

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Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.