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510(k) Data Aggregation

    K Number
    K163339
    Device Name
    SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
    Manufacturer
    SPECTRALMD, INC.
    Date Cleared
    2017-08-17

    (262 days)

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

    SPECTRALMD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpectralMD™ DeepView™ Wound Imaging System 2.0 is an optical imaging device 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, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers and diabetic ulcers.
    Device Description
    The DeepView System 2.0 is a prescription device that utilizes the principles of non-contact photoplethysmography (PPG) to capture images of tissue blood perfusion. This is accomplished by measuring the optical properties of tissues and blood as they vary in response to changing hemodynamic conditions. The device's software combines real-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images on a touch-screen display depicting relative blood perfusion. The DeepView System consists of a Camera Head with LED optics, an Articulating Arm for Camera Head positioning, a Touch-Screen Display for image viewing, and for accessing and interacting with the Graphical User Interface (GUI). All components are integrated on a Mobile Cart that houses the hardware/software, uninterruptable power supply (UPS), and allows for transport between use environments. The DeepView System 2.0 is AC powered with a backup UPS, and is for use in healthcare/hospital facilities.
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