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

    Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

    K Number: K213583 · Decision May 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    46
    Review Days
    185

    Basic Information

    Device Name
    Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
    K Number
    K213583
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Nederland B.V.
    Date Received
    November 12, 2021
    Decision Date
    May 16, 2022
    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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