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510(k) Data Aggregation

    K Number
    K013110
    Device Name
    ANISEIKONIA INSPECTOR
    Manufacturer
    OPTICAL DIAGNOSTICS, INC.
    Date Cleared
    2001-12-19

    (161 days)

    Product Code
    HJT
    Regulation Number
    886.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTICAL DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to assist in the detection and management of aniseikonia.
    Device Description
    The device is based on an old technique called 'direct comparison eikonometry'. I.e. the two eyes are offered a different image and the subject needs to determine if there is a size imbalance between the two images. If there is an imbalance in size, the size 16 a one of the images is changed until the subject perceives the two images as equal in size. The extent in which one of the images needed to be changed in size is a measure for the amount of aniseikonia of the subject. In The Aniseikonia Inspector the separation between the two eyes is accomplished by holding a red and a green filter in front of the eyes. The images are created on a computer screen and they can be altered by using a computer periheral such as the keyboard.
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