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510(k) Data Aggregation

    K Number
    K122589
    Device Name
    DFP4343C7
    Date Cleared
    2012-10-05

    (42 days)

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

    MDI CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Digital X-ray Detector DFP4343C7 is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a high-resolution digital imaging detector designed for general radiography. It is intended to replace conventional film radiography technique. DFP4343C7 consists of Electro X-ray Unit, Software package(S/P), Power Supply Unit and cables set. DFP 4343C7 is an X-Ray image acquisition device that is based on flatpanel. This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
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