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

    Prodiva 1.5T CX and Prodiva 1.5T CS R5.4

    K Number: K173507 · Decision Jun 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    17
    Review Days
    214

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    Basic Information

    Device Name
    Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
    K Number
    K173507
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Received
    November 13, 2017
    Decision Date
    June 15, 2018
    Product Code
    LNH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNH System, Nuclear Magnetic Resonance Imaging

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