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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    NEUROVISION, INC.

    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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