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510(k) Data Aggregation

    K Number
    K202235
    Device Name
    ArtPIX DRF
    Date Cleared
    2020-09-03

    (27 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMT Medical Technologies Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ArtPIX DRF is a digital image acquisition system to be used with integrated solid state detector, during radiography or fluoroscopy x-ray examination, to capture digitalize, review images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.
    Device Description
    The modified ArtPIX DRF is a dynamic digital radiography system including fluoroscopy and radiography capabilities. The system application is based on Windows 10 operating system. The object-oriented software performs real-time image processing (based on parallel computing), and full procedures storage. The DICOM 3.0 IHE compliant connectivity provides the tools to transmit patient demographics, examinations and image data in digital format. Parameters for X-ray exposure, review, post-processing operations and filming can be set up from a single console, significantly increasing clinical efficiency. The modified ArtPix DRF operates in connection with the dynamic Pixium 2121, 3030, 4343 flat panel detectors and 2430, 3543 portable flat panel detectors (made by Thales of Moirans, France). The modified ArtPix DRF is intended for OEMs and Integrators that will integrate the product with their R&F table as a digital supplement.
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