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510(k) Data Aggregation

    K Number
    K092713
    Device Name
    SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
    Date Cleared
    2010-07-16

    (316 days)

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

    TRANSAMERICAN MEDICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spectre System is intended for use with compatible diagnostic x-ray systems in hospitals or outpatient facilities. The Spectre System is indicated for use as an accessory to provide input control to compatible x-ray systems. This accessory includes a wireless footswitch, a wireless hand switch, and a receiver. It is cleared for use for the particular indications of the x-ray system to which it is attached.
    Device Description
    The Spectre System is an alternate option to the existing cabled foot switch and hand switch for users of Xray systems. It consists of three parts-a footswitch/transmitter, a hands switch/transmitter, and a receiver. The Spectre system receiver connects to the x-ray system through the same connector as the current footswitch, and operates the x-ray system by exactly emulating the functionality of the current cabled footswitch and hand switch. There are no cables, therefore, no trip hazards, contamination hazards, or cable breakage hazards. The footswitch and hand switch are powered by batteries, eliminating shock hazards. The receiver is mounted on the predicate device, and is powered from the predicate device.
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