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510(k) Data Aggregation

    K Number
    K102412
    Device Name
    VISTA DIGITAL OPTHALMOSCOPE
    Manufacturer
    EYEQUICK.LLC
    Date Cleared
    2011-06-23

    (303 days)

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

    EYEQUICK.LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
    Device Description
    The EyeQuick Digital Ophthalmoscope Camera is an ophthalmoscope with an integrated digital camera. The system includes an LCD viewfinder and can be used handheld without any cables. The Digital Ophthalmoscope has on board memory to store images which can be downloaded to a PC via a USB connection.
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