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510(k) Data Aggregation

    K Number
    K060486
    Device Name
    CYCLONE, MODEL MAICAM 180
    Manufacturer
    Date Cleared
    2006-03-23

    (27 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cyclone is an emission computed tomography system intended to detect the location and distribution of gamma ray emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The data can then be transmitted to, or retrieved by, existing commercially available image processing software packages and accompanying computer equipment. The Cyclone intended use is for cardiac applications. The Cyclone supports radionuclides within the energy of 50-200keV.
    Device Description
    The Cyclone camera is a dedicated Gamma Camera for nuclear cardiology. The intended use of Cyclone is to detect the location and distribution of gamma ray emitting radionuclides in the body and store the image data. This device includes accessories such as signal analysis and display equipment, patient and equipment supports. radionuclide anatomical markers, component parts, and accessories. Radiopharmaceuticals are administered intravenously. The Cyclone records the distribution of the tracer in vivo. Gamma rays are emitted from the tracer. A collimator is used to accept only the gamma rays with defined orientations, usually parallel for detection. The collimator is actually analogous to a camera lens. The gamma rays admitted into the scintillation camera detector interact with a scintillating crystal, causing a very small flash of light at each point of interaction. The crystal is large, flat and thin (see specifications for size). The pattern of light flashes is detected by photomultiplier tubes that convert the light into electrical signals, each signal proportional to the energy of the gamma ray and also carrying precise positional information. Only gamma rays with the correct energy for the tracer used and with meaningful orientation to the patient are imaged. The Cyclone camera consists of a base which supports a wall or track that in turn supports and guides a fixed 90 degree dual head around a patient chair. The motions and set-up of the camera can be controlled with the hand control. Detector motions are controlled by software and are initiated by the hand control.
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