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510(k) Data Aggregation

    K Number
    K061302
    Device Name
    DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
    Manufacturer
    MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS
    Date Cleared
    2006-06-23

    (44 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.
    Device Description
    Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on 8x10" sized film/thermal paper. It does not incorporate laser scanning unit. The control unit processes and controls image data and performs control of the whole device. This device is not intended for mammography use.
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