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510(k) Data Aggregation

    K Number
    K220149
    Device Name
    General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
    Date Cleared
    2022-04-19

    (90 days)

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

    **XERA Medical Systems **& Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications.
    Device Description
    This device consists of X-ray control, high-voltage generator, X-ray tube support, irradiation equipment, detectors, patient photography stand, digital imaging device, viewer SW, etc. The detectors and the viewer SW are cleared under the following 510ks. - VIVIX-S VW(K200418) . Model Names: FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively. A high frequency inverter (Inverter) X-sensor voltage device designed to generate X-rays by combination of tube voltage, tube current, irradiation time, etc. so that it can be filmed at various angles for diagnosis of the patient's skeletal, respiratory, and urinary systems. The digital imaging system is used to obtain the images taken by the X-ray unit as radiation from the X-ray unit passes through the human body and is transmitted by the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software, VXvue, acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors.
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