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    K Number
    K203667
    Device Name
    EzRay M (Model: VMX-P300)
    Manufacturer
    Vatech Co., Ltd
    Date Cleared
    2021-02-02

    (48 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K140723
    Why did this record match?
    Device Name :

    EzRay M (Model: VMX-P300)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EzRay M (Model: VMX-P300) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.

    Device Description

    EzRay M (Model: VMX-P300), a medical portable X-ray system, operates on 21.6 Vdc supplied by a rechargeable Li-ion battery pack. The system is designed for medical examination and composed of an X-ray generating part with an X-ray tube including a device controller, a power controller, a user interface, a beam limiting part, and optional items. It is intended to be used by a qualified and trained clinician on adult patients. The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission.

    AI/ML Overview

    This is a 510(k) premarket notification for a mobile x-ray system, EzRay M (Model: VMX-P300). The document does not describe the acceptance criteria and a study that proves a device meets acceptance criteria for performance relevant to AI/ML. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NOMAD MD Handheld X-ray System, K140723) based on device characteristics, indications for use, and compliance with various international and federal safety standards for X-ray equipment.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, as this document does not contain that type of information. It is a regulatory submission for a traditional medical device (X-ray system), not an AI/ML powered device.

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