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    K Number
    K093071
    Device Name
    FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
    Manufacturer
    FUNDUS PHOTO, LLC
    Date Cleared
    2010-11-17

    (413 days)

    Product Code
    HKINFFNFGSUB
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUNDUS PHOTO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.
    Device Description
    The Fundus Photo Digital Imaging System Model CFD-440 is an automated imaging device used in conjunction with an ophthalmic fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires nominal training for a user to become proficient. Like the predicate device, the Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform intended to capture, store, archive, and display images acquired by the fundus camera.
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