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510(k) Data Aggregation

    K Number
    K983826
    Device Name
    3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
    Manufacturer
    UNIMACHS CORP.
    Date Cleared
    2000-03-23

    (511 days)

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

    UNIMACHS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3S INJECTOR - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT). The 3S INJECTOR - CT is intended for the administration of contrast media into patients for diagnostic x-ray studies.
    Device Description
    The Nemoto 3S Injector- CT is an auto injector system developed to meet the needs of physicians and provide accurate and steady injection rate, time, volume and enhanced safety. The 3S Injector - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT). The Injector system is composed of three main components: the master control and display unit, the injector head and a remote Control unit. The Iniector's master control unit uses function kevs and can store up to 20 protocols. The 3S INJECTOR - CT is designed for single- use, disposable svringes of 100ml and 200ml. The single-use svringes are manufactured of polypropylene, have the same intended use and perform similarly to those of predicate devices.
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