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

    FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

    K Number: K250455 · Decision Apr 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    58

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
    K Number
    K250455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    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
    February 18, 2025
    Decision Date
    April 17, 2025
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QDG), ordered by most recent decision date.

    Dendrite Imaging System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

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

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FLUOBEAM® LX Red

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Fluobeam LX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all