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510(k) Data Aggregation

    K Number
    K033783
    Device Name
    IMALUX OCT IMAGING SYSTEM
    Manufacturer
    IMALUX COPORATION
    Date Cleared
    2004-03-01

    (88 days)

    Product Code
    NQQ
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMALUX COPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imalux OCT (Optical Coherence Tomography) Imaging System is intended to be used as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
    Device Description
    The Imalux OCT (Optical Coherence Tomography) Imaging System utilizes near infrared (NIR) light to create high spatial resolution, real-time images near infrared (1127) be Imalux OCT Imaging System consists of an Imaging Console and a detachable, flexible fiberoptic Probe. The Imaging Console Console and a detailsptical and electrical components and a user interface system. The user interface system includes a keyboard, display, and standard Ethernet and USB ports for image data transfer. As various tissue structural elements absorb, reflect, and scatter light As various NIR light that is backscattered from the tissue is collected and analyzed to present an image of the tissue microstructure. By analyzing andly200 to probesity as a function of tissue depth, over a lateral surface, a 2-dimensional image is constructed. At any one lateral position, the in-depth OCT image is analogous to an At any one accrar presents backscattering intensity as a function of depth. By combining the in-depth scanning with lateral movement of the depth. Dy connemional image is created that is analogous to that of ultrasound B-scan, except that OCT uses light in lieu of sound waves. By using light instead of sound, the Imalux OCT Imaging System can achieve higher spatial resolution, but to a more shallow imaging depth, than ultrasound imaging since light is more readily attenuated in the tissue.
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