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510(k) Data Aggregation

    K Number
    K170480
    Device Name
    Models 3543A, 4343A, 2929A and A843B
    Manufacturer
    Shanghai PZ Medical Technolgoy Co., Ltd.
    Date Cleared
    2017-07-07

    (141 days)

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

    Shanghai PZ Medical Technolgoy Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model#'s 3543A, 4343A, 2929A and A843B; Solid State X-ray Imager (Flat Panel/Digital Imager) are indicated for use in generating radiographic images of human anatomy. They are intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, and mammographic applications. As prescribed by a licensed physician
    Device Description
    Our device is used in medical x-ray imaging systems. The product can only be used by trained personnel of medical facilities. The product is only used for single image diagnosis applications. The flat panel detector consists of GOS scintillator screen and thin-film transistors. The scintillator screen converts the x-rays into visible light. Thin-film transistors convert the visible light to an electrical charge. The flat panel detector can then obtain a digital image by analog to digital conversion and associated circuits.
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