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510(k) Data Aggregation

    K Number
    K050350
    Device Name
    THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
    Manufacturer
    NOTAL VISION, INC.
    Date Cleared
    2005-04-29

    (77 days)

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

    NOTAL VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PreView PHP™ is intended for use in the detection and monitoring the progression of Agerelated Macular Degeneration (AMD) including, but not limited to, the detection of choroidal neovascularization (CNV). The PreView Preferential Hyperacuity Perimeter (PreView PHP™) is intended for use in The detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration , as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to progression of assouse ration (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.
    Device Description
    The PreView PHP™ system is an interactive software driven device that provides a series of horizontal and vertical linear images to the macular region of the eye to detect abnormalities of the central and paracentral visual field that will detect and monitor progression of age related macular degeneration including detection of choroidal neovascularization. The changes in macular and near macular function are identified by the device thus enabling the reader to detect intermediate and advancing changes in macular degeneration and associated diseases to provide the capability for earlier intervention. The PreView PHP™ is a specialized perimeter, and applies the concept of the static and automated permeter in the detection of visual field defects. The device incorporates the theory of hyperacuity to address more highly specific central and paracentral visual fields. Because of hyperacuity, perception of more finite relative spatial localization. Hyperacuity is defined as the ability to perceive a difference in the relative spatial localization of points on the central field, more specific distortions or misalignments within the central and paracentral field can be mapped with greater accuracy. The device monitors and manages the progressive changes associated with advancing macular degeneration and differentiates the different stages of AMD including but not limited to choroidal neovascularization. The PreView PHP™ system is designed for use with standard off-the-shelf PC units in the office of the practitioner. It is aimed to detect advancing changes of AMD-related lesions including but not limited to choroidal neovascularlization.
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    K Number
    K014044
    Device Name
    MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
    Manufacturer
    NOTAL VISION, INC.
    Date Cleared
    2002-03-04

    (87 days)

    Product Code
    HOQ
    Regulation Number
    886.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOTAL VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for The early detection of central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with macular degeneration.
    Device Description
    The device is a computerized interactive software device that provides the user with a series of images oriented in vertical and horizontal planes on a imaging screen that is designed to identify irregularities in the central and paracentral macular field of the human visual system. The device analyzes the image presentation in the process of identifying visual field abnormalities and stores the analysis in a computer server. The device is housed in a PC computer.
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