BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Vantage Titan 3T, MRT-3010/A7, M-Power GX

    K Number: K172878 · Decision Nov 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    9
    Review Days
    57

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    Basic Information

    Device Name
    Vantage Titan 3T, MRT-3010/A7, M-Power GX
    K Number
    K172878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Toshiba Medical Systems Corporation, Japan
    Date Received
    September 21, 2017
    Decision Date
    November 17, 2017
    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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