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510(k) Data Aggregation

    K Number
    K092565
    Device Name
    DIGITAL RETINAL CAMERA CX-1
    Manufacturer
    CANON COMPONENTS, INC.
    Date Cleared
    2010-03-18

    (210 days)

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

    CANON COMPONENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
    Device Description
    The DIGITAL RETINAL CAMERA CX-1 is used for taking digital images of retina of human eye with non-mydriatic and mydriatic. is mounted with CX-1, can be viewed immediately, making Digital Camera (Dedicated) procedures more efficient and many different applications, such as telemedicine and electronic filing.
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