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510(k) Data Aggregation

    K Number
    K181269
    Device Name
    iCertainty
    Manufacturer
    Date Cleared
    2018-12-14

    (214 days)

    Product Code
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rfpi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iCertainty System is intended for non-invasive two-dimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm.
    Device Description
    The iCertainty System is a device used to image blood flow distribution (flow in vessels and perfusion in tissues) in real time. The device employs a mobile cart so that it can be configured in the appropriate orientation to properly image the tissue in an operating room environment without restrictions. When a practitioner elects to use imaging as an adjunct to evaluate blood flow distribution the device is moved into the appropriate position and an extension arm with an optical head unit (OHU, containing the lasers/camera equipment) is positioned over the patient as described in the instructions for use. The OHU is moved to a specified height (focused) over the target image area and the imaging is performed. The imaging can be performed as often as deemed necessary by the surgeon during the procedure to visualize blood flow distribution (blood flow in vessels and perfusion in tissues) in the target tissues being operated upon. The device employs a dual laser-based system with a camera imaging system. The two lasers (450nm and 785nm) illuminate the surface and blood flow distribution up to a depth of 4-5mm of the target tissue. A digital camera records the image in real time. All real-time blood flow distribution analyses are performed on a central computer within the device. Realtime images are displayed to the surgeon on an imaging display. Data entry is performed on a separate display and data entry keyboard. A sterile drape is used as an accessory to protect the sterile operating field from contamination during use.
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