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510(k) Data Aggregation

    K Number
    K170527
    Device Name
    Phoenix Clinical ICON
    Manufacturer
    Phoenix Technology Group, Inc. dba Phoenix Clinical
    Date Cleared
    2017-09-15

    (205 days)

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

    Phoenix Technology Group, Inc. dba Phoenix Clinical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General ophthalmic imaging including retinal, corneal, and external structures of the eye.
    Device Description
    The Phoenix Clinical ICON is a battery and AC-powered, cart-based, non-sterile, wide-field, handheld, high resolution, real-time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix Clinical ICON are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The Phoenix Clinical ICON may be used in hospitals, medical clinics, and physician's offices. The Phoenix Clinical ICON is a system comprised of a hand-held camera with an interchangeable LED based light source incorporated into the hand piece that is attached to the cart contains the battery, the keyboard controls, monitor, attached foot pedal, and computer with software. The hand piece is designed such that the glass lens in the tip will come into contact with the cornea. LED light is emitted into the eye to illuminate the retina for image capture. The Phoenix ICON is operated by attaching the appropriate module (white or blue LED) to the handpiece and, after the software is running, placing the camera lens in direct contact with the patient's cornea. The Phoenix Clinical ICON software can capture either video or still images and store them on the cart computer for later review. The Phoenix Clinical ICON may be connected to, under IT supervision, IT networks.
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