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510(k) Data Aggregation

    K Number
    K212051
    Device Name
    RFA-1717DIG, RFA-1717DIC
    Manufacturer
    Date Cleared
    2021-08-25

    (56 days)

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

    ASTEL Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RFA-1717DI detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
    Device Description
    The RFA-1717DI detector is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature. Giga-bit Ethernet communication method through connection of tether cable. The RFA-1717 detector is available in two types of scintillator: Csl: Tl type for RFA-1717DIC model and Gadox:Tb type for RFA-1717DIG model. The device accepts x-ray photons and the scintillator and emits visible spectrum photons that illuminate an array of photo (IGZO)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis and imaging data management on network.
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