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

    RETCAM 3 OPTHALMIC IMAGING SYSTEM

    K Number: K102859 · Decision Apr 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    4
    Review Days
    202

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    Basic Information

    Device Name
    RETCAM 3 OPTHALMIC IMAGING SYSTEM
    K Number
    K102859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarity Medical Systems
    Date Received
    September 30, 2010
    Decision Date
    April 20, 2011
    Product Code
    HKI
    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
    HKI Camera, Ophthalmic, Ac-Powered

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    Other Clearances by Clarity Medical Systems

    K Number Device Name
    K090326 RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
    K083771 RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
    K081858 RETCAM 3 OPHTHALMIC IMAGING SYSTEM