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510(k) Data Aggregation

    K Number
    K092433
    Device Name
    DYSIS
    Manufacturer
    FORTH PHOTONICS HELLAS SA
    Date Cleared
    2011-03-10

    (580 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTH PHOTONICS HELLAS SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DySIS with Pseudo-Color Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.
    Device Description
    DySIS offers non-patient contact, fully digital and high-resolution imaging of the cervix. The field of view is illuminated by an LED; a CCD camera coupled with the imaging optics provides crisp magnified color images. The images can be viewed on a color monitor and on the color touch screen that provides the means to control the device operation. DySIS offers digital tools to fully document the colposcopic examination: Capturing of images for review, storage and printing, video recording. Advanced magnification and imaging. Operator's annotation of suspicious sites. Color-coded mapping of acetowhitening intensity and duration. Database that allows storing and retrieving identification and examination data.
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