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    K Number
    K042041
    Device Name
    XPLORER 1600
    Manufacturer
    IMAGING DYNAMICS COMPANY LIMITED
    Date Cleared
    2004-09-17

    (50 days)

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

    IMAGING DYNAMICS COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.
    Device Description
    A stationary x-ray system with CCD imager
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