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

    TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T

    K Number: K013894 · Decision Jan 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    71
    Review Days
    56

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    Basic Information

    Device Name
    TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
    K Number
    K013894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    November 23, 2001
    Decision Date
    January 18, 2002
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

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