Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130003
    Device Name
    XIRALITE FLOURESCENCE IMAGING SYSTEM X4
    Manufacturer
    Date Cleared
    2014-01-31

    (394 days)

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

    MIVENION GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands.
    Device Description
    The Xiralite fluorescence imaging system X4 detects fluorescence signals in the defined field of view using a highly sensitive camera for signal detection and light emitting diodes (LEDs) for excitation. Fluorescence signals typically result from illumination of a specific fluorophore, the fluorescence dye indocyanine green (ICG), which is administered intravenously. Fluorescence signals are recorded at different periodical time points, thus the resulting images display an image sequence. The frame rate is between half a second and a few seconds, typically one second. The duration of the entire image acquisition is dependent on the pharmacokinetics of the administered fluorophore, with ICG typically six minutes.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1