BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SCANVIEW SYSTEM

    K Number: K110345 · Decision Oct 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    257

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    Basic Information

    Device Name
    SCANVIEW SYSTEM
    K Number
    K110345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.4700
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Spectral Imaging
    Date Received
    February 4, 2011
    Decision Date
    October 19, 2011
    Product Code
    NTH
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

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