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510(k) Data Aggregation

    K Number
    K192761
    Device Name
    Asimov-MKS Imaging System
    Manufacturer
    Date Cleared
    2020-01-17

    (109 days)

    Product Code
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    OnLume Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Asimov-MKS Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries.
    Device Description
    The Asimov-MKS Imaging System is a fluorescence angiography imaging system. It is a prescription device intended to be used in hospital surgical suites, ambulatory surgery centers, and similarly equipped healthcare facilities. The Asimov-MKS Imaging System consists of an imager mounted to the distal end of an articulated arm that is affixed to a mobile cart. Under the supervision of the surgeon, the imager illuminates a region of interested with near infrared and/or white light. Cameras, integral to the imager, acquire fluorescence and/or white light color images and direct the acquired images to processing hardware within the cart. The articulated arm allows the imager to be directed at the region of interest. The arm affords unencumbered access to the patient and permits the cart to be positioned outside of the sterile field. The cart allows the Asimov-MKS Imaging System to be positioned as needed for a surgical procedure and to be relocated within a facility for additional procedures or storage. The cart houses the processing hardware that display and record the acquired images. Software executed on the processing hardware provides secondary functions such as patient biographical data entry, image review, and data archive. To maintain the sterile surgical field, a sterile drape covers the imager and portions of the arm during clinical use. The single use drape streamlines device cleaning after use. The fluorescent imaging agent utilized is indocyanine green (ICG). ICG is injected into the patient's blood stream, rapidly binds to the blood plasma, and is transported on the blood from the injection point to the region of interest. The ICG fluoresces when illuminated with the near infrared light emitted by the imager. Images of the fluorescence allow the clinician to visually assess circulation and related tissue perfusion.
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