Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K200787
    Device Name
    BSD3543W
    Manufacturer
    Date Cleared
    2020-04-23

    (28 days)

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

    Bontech Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BSD3543W (BT-DA22W/BT-DB22W) 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
    BSD3543W (BT-DA22W/BT-DB22W) is a digital X-ray flat panel detector which intercepts x-ray photons and the scintillator (BT-DB22W(Gdos) / BT-DA22W(CsI)) emits visible spectrum photons that illuminate an array of photo (a-SI)-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, all kinds of information management, and sharing of image information on network. The BSD3543W is a wireless version of the predicate device, the BSD3543.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1