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510(k) Data Aggregation

    K Number
    K093624
    Device Name
    OPTISCAN MODEL OPTISCAN CEIS
    Manufacturer
    Date Cleared
    2010-03-05

    (102 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTISCAN PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
    Device Description
    The Optiscan Confocal Endoscopic Imaging System (CEIS) is a software controlled device which is intended for use as a required accessory with a legally marketed and compatible video endoscope system that is equipped with confocal imaging module. The Confocal Endomicroscopy Imaging System (CEIS) consists of three main units. - The Control Unit (CEIS-CU) together with its monitor, keyboard, and footswitch, 1. is a computer based unit which performs the instrument control, and image capture and processing functions of the CEIS. - The Optical Unit (CEIS-OU) a specialised endomicroscope interface unit which 2. performs the laser illumination and fluorescence detection functions of the CEIS. - 3. The Isolation Transformer. A video endoscope equipped with a confocal imaging module is connected to the CEIS-OU. Under control by the endoscopist, the CEIS-OU transmits visible laser light into the connected endoscope. The endoscope transmits this light to and then subsequently receives return light signals from the subject tissue. The returned light is detected by the CEIS-OU and converted into an electrical signal. The detected signal is sent to the System Computer (CEIS-CU) which processes the confocal image information for display on the system monitor, and allows still images of the tissue to be captured and stored.
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