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510(k) Data Aggregation

    K Number
    K161237
    Device Name
    HyperView Hyperspectral Tissue Oxygenation Measurement System
    Date Cleared
    2016-12-16

    (228 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYPERMED IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HyperView™ Hyperspectral Tissue Oxygenation Measurement System is intended for use by physicians/healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of. - · oxygen saturation (O2Sat), - · oxyhemoglobin level (Oxy), and - deoxyhemoglobin (Deoxy) level in superficial tissue. The HyperView™M system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions. The HyperView™ system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
    Device Description
    HyperMed Imaging Inc.'s HyperView handheld hyperspectral imaging system consists of the HyperView Camera and the HyperView Accessories Kit that includes a Docking Station, Calibration Verification System, Power Cord and USB Cable Set. The HyperView system provides noninvasive measurement of approximate tissue oxygenation, sensitive to local, regional, and systemic low/no-flow ischemia. HyperView uses multi-wavelength imaging technology to analyze the signature of light as it is absorbed by the patient's tissue. The HyperView system analyzes these light absorption signatures to measure oxyhemoglobin and deoxyhemoglobin levels in the tissue, and creates a color-coded image that illustrates relative concentrations of oxygenated hemoglobin and deoxygenated hemoglobin. Quantitative data is provided for oxyhemoglobin and deoxyhemoglobin levels as well as oxygen saturation. The technology is suitable for surface assessment, as the visible spectrum light used penetrates no more than a few millimeters deep. The HyperView is a handheld product consisting of several subassemblies including precision optical components, electro-optics, imaging sensor, a thermal sensor, flash illumination, flex circuits, printed circuit boards, a battery, plastics as well as image processing and graphics user interface software. Users will interact with the device using a built-in, resistive, touchscreen display and an image capture button similar to a digital camera. The product does not come in contact with the patient and no injectable contrast is required. The camera uses visible light to momentarily illuminate the patient's skin for photographic imaging. Such information is useful in determining viability of vascular delivery in the superficial skin and correspondingly, such information can assist the physician in determining the ability of the patient's vascular system to support normal tissue health and wound healing.
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