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

    OPTIS Metallic Stent Optimization E.4 SW

    K Number: K160878 · Decision Jun 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    40
    Applicant Total
    7
    Review Days
    91

    Basic Information

    Device Name
    OPTIS Metallic Stent Optimization E.4 SW
    K Number
    K160878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LIGHTLAB IMAGING, INC.
    Date Received
    March 30, 2016
    Decision Date
    June 29, 2016
    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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