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

    OASIS MRI SYSTEM

    K Number: K093044 · Decision Mar 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    9
    Applicant Total
    100
    Review Days
    167

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    Basic Information

    Device Name
    OASIS MRI SYSTEM
    K Number
    K093044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Systems America, Inc.
    Date Received
    September 30, 2009
    Decision Date
    March 16, 2010
    Product Code
    LNI
    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
    LNI System, Nuclear Magnetic Resonance Spectroscopic

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