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510(k) Data Aggregation

    K Number
    K992529
    Device Name
    TISSUE SPECTROSCOPE
    Manufacturer
    VITAL MEDICAL LTD.
    Date Cleared
    2000-11-17

    (478 days)

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

    VITAL MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.
    Device Description
    The Tissue Spectroscope is a device that carries out various in-vivo, spectroscopic measurements. It is a combination device consisting of an NADH Fluorometer and a Laser Doppler Flowmeter. The Tissue Spectroscope is used to transmit radiation at a known wavelength through tissue and to measure the fluorescence of NADH and the intensity of light reflected from the tissue, including the Doppler shift arising from the moving red blood cells. The Tissue Spectroscope measures the following three parameters: 1. Mitochondrial NADH fluorescence at 420 nm to 480 nm. 2. Doppler shifted laser light (325nm) reflected from moving blood cells. 3. Total backscattered light (325nm) reflected from the tissue. This parameter allows for correction of the NADH fluorescence measurement due to changes in tissue blood volume. These three parameters contain information, respectively, pertaining to the redox state of mitochondrial NAD/NADH of the tissue, microvascular blood flow in the tissue and total blood volume of the tissue. Changes in these values reflect changes in the balance between oxygen supply and oxygen demand.
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