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510(k) Data Aggregation

    K Number
    K063310
    Device Name
    TRUEFIELD ANALYZER
    Manufacturer
    SEEING MACHINES LIMITED
    Date Cleared
    2007-08-02

    (273 days)

    Product Code
    HPT
    Regulation Number
    886.1605
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEEING MACHINES LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueField Analyzer is an automated perimeter used to aid in measurement of visual field abnormalities. For the assessment of visual field abnormalities.
    Device Description
    The TrueField Analyzer is an automated perimeter that is used to aid in measurement of visual field abnormalities. It is an objective device that monitors involuntary responses in the patient's pupils to a series of multi-focal visual stimuli presented to the eyes. The system presents stimuli and monitors the pupil responses in both eyes independently and concurrently. The device includes: - a bilateral image display system for providing individual visual stimulus to the patient's eyes (both eyes are concurrently and independently stimulated) - A pair of video cameras for monitoring the patient's pupils again concurrently and independently - A personal computer equipped to run Windows XP Professional Service Pack 2 operating system. - The TrueField Software system. The TrueField Software automatically manages the stimulus presentation and video data acquisition, ensuring synchronization between the display and video image acquisition; data analysis, storage and presentation of results for review. The TrueField Analyzer uses a different fundamental technology to the predicate device. It combines standard multi-focal stimulus and analysis technology (as used in other perimetry devices, for example K003442, K983983) with computerized pupil monitoring (for example K920937) allowing the device to objectively measure the visual field map of a patient. In doing so it is substantially equivalent to the predicate device (K954167).
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