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510(k) Data Aggregation

    K Number
    K183059
    Device Name
    3nethra neo
    Date Cleared
    2018-12-21

    (49 days)

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

    Forus Health Pvt. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.
    Device Description
    The 3nethra neo is a compact, portable and easy to use, mydriatic, digital wide field imaging camera used for the photo documentation of ocular diseases that manifest in infant eyes. 3nethra neo needs to be connected to a computer for running the application software, to store, view, retrieve, and export the digital ophthalmic images. The 3nethra neo has a hand-held probe unit, a control box and a foot-pedal control unit. Warm white LED with intensity control via foot-pedal is used to provide illumination to the eye in order to capture images.
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