BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    LuminScan (TM) Imaging System

    K Number: K162466 · Decision Nov 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    45
    Applicant Total
    41
    Review Days
    88

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    Basic Information

    Device Name
    LuminScan (TM) Imaging System
    K Number
    K162466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    September 2, 2016
    Decision Date
    November 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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