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510(k) Data Aggregation

    K Number
    K160143
    Device Name
    ClearVision ExamVue Flat Panel Detector
    Manufacturer
    JPI HEALTHCARE, INC
    Date Cleared
    2016-10-28

    (281 days)

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

    JPI HEALTHCARE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.
    Device Description
    The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector 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. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ClearVision ExamVue Flat Panel Detector use aSi 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: - a. A 14x17in (35x43cm) tethered cassette sized panel - b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection - c. A 17x17in (43x43cm) tethered panel for fixed installations.
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