BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

    K Number: K063388 · Decision Jun 22, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    30
    Same Product Code
    65
    Applicant Total
    9
    Review Days
    226

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    Basic Information

    Device Name
    TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
    K Number
    K063388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Corp.
    Date Received
    November 8, 2006
    Decision Date
    June 22, 2007
    Product Code
    OBO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OBO Tomography, Optical Coherence

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