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510(k) Data Aggregation

    K Number
    K251410

    Validate with FDA (Live)

    Device Name
    VXvue
    Manufacturer
    Vieworks Co., Ltd.
    Date Cleared
    2025-11-04

    (181 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K231225
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VXvue is intended to acquire Digital images from X-ray Detectors, process the images to facilitate diagnosis and to display, and transfer the resulting images to other devices for diagnostic purpose.

    VXvue is indicated for use in general radiographic images of human anatomy. And it is not for fluoroscopic, angiographic, and mammographic applications.

    Device Description

    VXvue gets images from a detector, processes, and transfers the images and manages patient's information and the images for radiologists. VXvue enables images such as x-ray images to be stored electronically and viewed on screens.

    VXvue offers full compliance with DICOM (Digital Imaging and Communications in Medicine) standards to allow the sharing of medical information with other PACS (Picture Archiving and Communication System Server). Besides, VXvue is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation and enhancement.

    AI/ML Overview

    N/A

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