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510(k) Data Aggregation

    K Number
    K180895
    Device Name
    Alleye
    Manufacturer
    Oculocare Medical AG
    Date Cleared
    2018-06-27

    (83 days)

    Product Code
    HOQ
    Regulation Number
    886.1330
    Why did this record match?
    Product Code :

    HOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alleye is a mobile medical software application indicated for the detection and characterization of metamorphopsia, a visual distortion, in patients with age-related macular degeneration (AMD) and as an aid in the monitoring of the progression of this condition in respect of metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home.
    Device Description
    Alleye is a digital technology visual function test, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Alleye implements an alignment hyperacuity task that helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or monitoring the visual function associated with ongoing treatments. Two elements provide feedback about the Alleye test: a score and a colored circle. The score value reflects the visual performance in the dots alignment, whereas the color indicates whether the performance has worsened considerably (red) or remained stable or improved (green) compared to the previous test.
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    K Number
    K143211
    Device Name
    myVision Track Model 005
    Manufacturer
    VITAL ART AND SCIENCE INCORPORATED
    Date Cleared
    2015-03-20

    (130 days)

    Product Code
    HOQ, HOO, HPT
    Regulation Number
    886.1330
    Why did this record match?
    Product Code :

    HOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The my VisionTrack® Model 0005 is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrack® Model 0005 is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
    Device Description
    The myVisionTrack® Model 0005 is a vision function test provided as a downloadable app on to the user's supplied cell phone or tablet. The myVisionTrack® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
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    K Number
    K121738
    Device Name
    MYVISIONTRACK(TM)
    Manufacturer
    VITAL ART AND SCIENCE INCORPORATED
    Date Cleared
    2013-02-22

    (254 days)

    Product Code
    HOQ, HPT
    Regulation Number
    886.1330
    Why did this record match?
    Product Code :

    HOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The my Vision TrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
    Device Description
    The myVisionTrack™ is a vision function test provided on a commercially available cell phone. The myVisionTrack™ implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. This enables regular monitoring of disease progression, and for timely detection of significant changes in vision function. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
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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?
    Product Code :

    HOQ

    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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