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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?
    Product Code :

    HJT

    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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    K Number
    K012530
    Device Name
    AA-1 SYSTEM
    Manufacturer
    NEUROVISION, INC.
    Date Cleared
    2001-08-31

    (25 days)

    Product Code
    HJT
    Regulation Number
    886.1340
    Why did this record match?
    Product Code :

    HJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AA-1 System is indicated for the treatment of amblyopia using an interactive computerized program in patients 9 years or older suffering from amblyopia. The Vision Treatment System is indicated for the treatment of amblyopia using and The Vision Treatment System is mateated to: and older suffering from amblyopia.
    Device Description
    The device is a computerized interactive device that provides the user with a series of linear images oriented in vertical and horizontal planes on a video imaging screen that is designed to identify and correct visual dysfunction from reduced visual acuity by re-training the eye to utilize its optimal visual response in gaining an increased awareness of visual acuity through a series of training sessions. The device analyzes the patient's visual acuity deficiencies and sets a program for the user to increase the demand on the visual system resulting in an improvement of visual acuity. The device pre-programs a series of visual stimuli tasks and takes the patient through a series of interactive functions in identifying various objects on the video screen, and helps to provide an environment that increases visual response.
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