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510(k) Data Aggregation

    K Number
    K102651
    Device Name
    ISCREEN VISION SCREENER
    Date Cleared
    2011-01-12

    (120 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCREEN VISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.
    Device Description
    The device consists of an illumination source and camera to record and measure the retinal reflex and ocular status for later analysis by an appropriate expert. Certain features of the device have been modified from the predicate design to enhance ease of use and in response to user feedback, e.g., the patient positioning system has been modifications include the addition of a second flash, a smaller form factor, and integration of the previously separate PC screen and keyboard into the device casing.
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