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510(k) Data Aggregation

    K Number
    K181623
    Device Name
    Clarifi Imaging System
    Date Cleared
    2018-07-19

    (29 days)

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

    Modulated Imaging, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Clarifi™ Imaging System is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise. The Clarifi Imaging System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of: - Oxygen saturation (StO2) ● - Oxyhemoglobin (HbO2), and . - Deoxyhemoglobin (HbR) . in superficial tissue.
    Device Description
    The Clarifi Imaging System is a noninvasive non-contact imaging device used to visualize spatially-resolved functional parameters of biological tissue. The Clarifi Imaging System shares fundamental principles with other oximeters and tissue oxygenation measurement systems. Tissue oximetry exposes tissue to optical radiation of known wavelengths and captures the remitted light or reflectance. The remitted-back scattered light is then used to calculate the tissue constituents. Spectral analysis is used to measure tissue oxygen saturation (StO2), oxyhemoglobin (HbO2), deoxyhemoglobin (HbR), and total hemoglobin (HbT: superficial and subsurface hemoglobin) and determine tissue optical properties (absorption and scattering). The Clarifi Imaging System uses both visible (VIS) and near-infrared (NIR) wavelengths; other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths. The analysis for Clarifi is based on principles of multi-spectral imaging and Spatial Frequency Domain Imaging (SFDI). The Clarifi system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
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    K Number
    K153426
    Device Name
    Ox-Imager CS
    Date Cleared
    2016-12-21

    (392 days)

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

    MODULATED IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ox-Imager CS™ is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
    Device Description
    The Ox-Imager CSTM is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygen saturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations. The Ox-Imager™ CS is a non-contact imaging device to visualize spatially-resolved optical and functional parameters of biological tissue. The Ox-Imager CS shares fundamental principles with other oximeters and tissue oxygenation measurement systems. Spectral analysis is used to measure oxygen saturation (StO2), oxyhemoglobin (HbO2), deoxyhemoglobin (HbR) and determine tissue optical properties (absorption and scattering) using specific LED wavelengths and patterns. The Ox-Imager CS uses both visible (VIS) and near infrared (NIR) wavelengths; other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths. Tissue oximetry exposes tissue to optical radiation of known wavelengths and captures the remitted light or reflectance. The remitted back scattered light is then used to calculate the tissue constituents mentioned above based on principles of multispectral imaging and Spatial Frequency Domain Imaging (SFDI).
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