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510(k) Data Aggregation

    K Number
    K080180
    Device Name
    MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
    Date Cleared
    2008-06-11

    (139 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTICAL IMAGING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
    Device Description
    The modified RFI, like the cleared RFI, is a mydriatic fundus imaging camera intended for taking red-free images. The modified RFI, as the cleared device, comprises of the following sub-assemblies: - An optical system for illuminating and imaging the retina. The optical imaging includes a stroboscopic light source for sequential rapid imaging of the retina. - A high resolution CCD camera. - An electronic unit for driving the light source. - A software package for operating the system, controlling the illumination, grabbing the images, data browsing and data analysis. The device is also capable of using 35 mm film or using a digital camera similar to the predicate devices. Visible light is used for observation. Alignment and focusing is manual via the fundus camera controls. Under red-free imaging, the modified RFI provides, through a series of multiple flashes, the ability to observe and register the blood flow velocity and path of motion.
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    K Number
    K062416
    Device Name
    RETINAL FUNCTIONAL IMAGER (RFI)
    Date Cleared
    2006-11-17

    (92 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTICAL IMAGING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions with the information of blood flow (velocity) and path of flow in a retinal vessel, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
    Device Description
    The Retinal Functional Imager (RFI) is a mydriatic fundus imaging camera intended for taking red-free images. The RFI is comprised of the following subassys: - An optical system for illuminating and imaging the retina. The optical imaging includes a stroboscopic light source for sequential rapid imaging of the retina. - A high resolution CCD camera. - An electronic unit for driving the light source. - A software package for operating the system, controlling the illumination, grabbing the images, data browsing and data analysis. The device is also capable of using 35 mm film or using a digital camera similar to the predicate devices. Visible light is used for observation. Alignment and focusing is manual via the fundus camera controls, Under red-free imaging, the Retinal Functional Imager (RFI) provides, through a series of multiple flashes, the ability to observe and register the blood flow velocity and path of motion.
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