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

    MAGNETOM OPEN VIVA WITH PERMANENT MAGNET

    K Number: K994316 · Decision Jan 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    5
    Review Days
    23

    Basic Information

    Device Name
    MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
    K Number
    K994316
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS MEDICAL CORP.
    Date Received
    December 22, 1999
    Decision Date
    January 14, 2000
    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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