BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

    K Number: K233564 · Decision Dec 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    39

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    Basic Information

    Device Name
    FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
    K Number
    K233564
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fluoptics Sas (A Getinge Group Company)
    Date Received
    November 6, 2023
    Decision Date
    December 15, 2023
    Product Code
    QDG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QDG Parathyroid Autofluorescence Imaging Device

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