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510(k) Data Aggregation

    K Number
    K120982
    Device Name
    DIGITAL EYE-FUNDUS CAMERA
    Manufacturer
    MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)
    Date Cleared
    2012-09-28

    (179 days)

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

    MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of the fundus of the human eye and surrounding area.
    Device Description
    MilS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area. It is more efficient and suitable for many different applications, such as telemedicine and electronic filing.
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