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510(k) Data Aggregation

    K Number
    K060210
    Device Name
    MEDIPORT
    Manufacturer
    MAXANT TECHNOLOGIES, INC.
    Date Cleared
    2006-02-10

    (14 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAXANT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEDIPORT is a medical grade device to be used as a platform for PACS software or DICOM viewer software. It is intended for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories. In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required. This device in not qualified or intended for use for mammographic purposes.
    Device Description
    The MEDIPORT is a high performance medical grade computer with DICOM calibrated monitors that may be used as a platform for PACS software. It is designed for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories. It may also be used to access patient records or perform other functions that may be required.
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