BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T

    K Number: K110151 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    20
    Review Days
    63

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    Basic Information

    Device Name
    ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
    K Number
    K110151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Health Care
    Date Received
    January 18, 2011
    Decision Date
    March 22, 2011
    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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