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510(k) Data Aggregation

    K Number
    K190334
    Device Name
    MIMOSA Imager
    Date Cleared
    2019-11-01

    (260 days)

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

    MIMOSA Diagnostics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
    Device Description
    The MIMOSA Imager is a non-contacting, cordless, battery powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device captures spatially-resolved images that is triggered by the end user via a smartphone-app interface. By tracking the spectral signatures of dominant chromophores in the patient's superficial tissue, the device calculates and displays the StO2 estimate on the connected android device screen. The MIMOSA Imager is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that maps the tissue oxygen saturation (StO2) values to a spatially registered heatmap. The MIMOSA Imager 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 or reflected light. The remitted back scattered light is then used to calculate StO2 based on principles of multispectral imaging. Spectral analysis is used to measure StO2 using specific both visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths. Other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths.
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