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510(k) Data Aggregation

    K Number
    K124049
    Device Name
    DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
    Manufacturer
    Spectral MD, Inc
    Date Cleared
    2013-04-18

    (108 days)

    Product Code
    DPT
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spectral MD, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectral MD DeepView system is intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics.
    Device Description
    Deep View system-based technology combines real-time digital analysis of optical signatures, thereby sensitizing an imager to photon-tissue interactions deep below the skin's surface. These image signatures are unique to the body and relate directly to a person's dynamic nature - both in terms of the quantity and quality of important physiological properties. This technology is non-invasive and uses no harmful radiation such as X-rays and allows clinical investigators to look deeper into the body, delivering images of blood flow under the skin's surface without ever touching the patient. The DeepView system is composed of a mobile cart with uninterruptible power supply, a laptop computer with remote multimedia keyboard, an LCD screen mounted on a bracket that allows for side-to-side panning, a mechanical arm, a CMOS camera with DSP electronics, and disposable LED cartridges with an associated LED driver control board.
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