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

    MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

    K Number: K003575 · Decision Jan 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    9
    Applicant Total
    169
    Review Days
    58

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    Basic Information

    Device Name
    MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
    K Number
    K003575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GE Medical Systems
    Date Received
    November 20, 2000
    Decision Date
    January 17, 2001
    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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