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    K Number
    K002685
    Device Name
    CORDLESS COMPACT MOBILE X-RAY SYSTEM
    Manufacturer
    MEDISON RADIOLOGY SYSTEMS, INC.
    Date Cleared
    2000-09-15

    (18 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISON RADIOLOGY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993896
    Device Name
    MCA-601, C-ARM MOBILE
    Manufacturer
    MEDISON RADIOLOGY SYSTEMS, INC.
    Date Cleared
    2000-03-27

    (132 days)

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

    MEDISON RADIOLOGY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MCA-601, C-Arm Mobile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.
    Device Description
    High frequency X-ray generator and Image intensifier systems are mounted on C-arm transport mobile base.
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