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510(k) Data Aggregation

    K Number
    K010821
    Device Name
    ECHOSEED/IODINE-125 SEEDS, MODEL 6733
    Manufacturer
    MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
    Date Cleared
    2001-04-11

    (23 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    DBA NYCOMED AMERSHAM IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983314
    Device Name
    PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
    Manufacturer
    NYCOMED AMERSHAM IMAGING
    Date Cleared
    1999-02-19

    (151 days)

    Product Code
    IZQ
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    NYCOMED AMERSHAM IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.
    Device Description
    The Premica™-CT Contrast Media Delivery System consists of the following components: - the console consisting of the pump, the main control panel, and the power . supply, - . the remote control panel, - the remote test injection trigger (handswitch), and . - associated cables. . - . bottle insulators, and - pedestal, connector, and wheels. . The printer is provided as an accessory.
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