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510(k) Data Aggregation

    K Number
    K244010
    Device Name
    ExamVue Apex
    Manufacturer
    JPI Healthcare Co, Ltd
    Date Cleared
    2025-02-24

    (60 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI Healthcare Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The Exam Vue Apex flat panel x-ray detector system is not indicated for use in mammography.
    Device Description
    The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are: EVA 14W, with a 14x17in (35x43cm) wireless cassette sized panel EVA 17W, with a 17x17in (43x43cm) wireless cassette sized panel EVA 10W, with a 10x12 (24x30cm) wireless cassette sized panel
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    K Number
    K213057
    Device Name
    ExamVue Duo
    Manufacturer
    JPI Healthcare Co, Ltd.
    Date Cleared
    2022-02-18

    (149 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI Healthcare Co, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ExamVue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. ExamVue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. ExamVue Duo is not indicated for use in mammography.
    Device Description
    The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors and (optionally) generators and manufacturer supplied software for the acquisition and storage of digital x-ray studies. The ExamVue Duo software then provides a user interface for the viewing, annotating, and other workstation functions. Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.
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