BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Philips IntelliSite Pathology Solution

    K Number: K172174 · Decision Oct 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    104
    Review Days
    77

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    Basic Information

    Device Name
    Philips IntelliSite Pathology Solution
    K Number
    K172174
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Nederland B.V.
    Date Received
    July 19, 2017
    Decision Date
    October 4, 2017
    Product Code
    PSY
    Advisory Committee
    Pathology
    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
    PSY Whole Slide Imaging System

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