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

    RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER

    K Number: K061674 · Decision Aug 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    86
    Applicant Total
    6
    Review Days
    70

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    Basic Information

    Device Name
    RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
    K Number
    K061674
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Talia Technology , Ltd.
    Date Received
    June 14, 2006
    Decision Date
    August 23, 2006
    Product Code
    HLI
    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
    HLI Ophthalmoscope, Ac-Powered

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    Other Clearances by Talia Technology , Ltd.

    K Number Device Name
    K041290 RTA MODEL D RETINAL THICKNESS ANALYZER
    K031312 RTA MODEL D RETINAL THICKNESS ANALYZER
    K000731 MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
    K964137 RTA RETINAL THICKNESS ANALYZER
    K930518 TALIA LASER SLIT