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

    deepLive (OSP12 + DMS)

    K Number: K252851 · Decision Oct 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    29

    Basic Information

    Device Name
    deepLive (OSP12 + DMS)
    K Number
    K252851
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Damae Medical
    Date Received
    September 8, 2025
    Decision Date
    October 7, 2025
    Product Code
    NQQ
    Advisory Committee
    Radiology
    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
    NQQ System, Imaging, Optical Coherence Tomography (Oct)

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