BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Harmony Referral System with Harmony OCT Viewer (Octave)

    K Number: K253893 · Decision Jun 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    32
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    182

    Basic Information

    Device Name
    Harmony Referral System with Harmony OCT Viewer (Octave)
    K Number
    K253893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Healthcare Solutions EMEA Oy
    Date Received
    December 4, 2025
    Decision Date
    June 4, 2026
    Product Code
    NFJ
    Advisory Committee
    Radiology
    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
    NFJ System, Image Management, Ophthalmic

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    Other Clearances by Topcon Healthcare Solutions EMEA Oy

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