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

    ULTRAGUIDE MR-GUIDE 3000

    K Number: K011418 · Decision May 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    ULTRAGUIDE MR-GUIDE 3000
    K Number
    K011418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultraguide , Ltd.
    Date Received
    May 9, 2001
    Decision Date
    May 24, 2001
    Product Code
    LNH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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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    Other Clearances by Ultraguide , Ltd.

    K Number Device Name
    K023227 USG 2000SA
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    K013150 MR-GUIDE 2000
    K002258 ULTRAGUIDE CT-GUIDE 1010
    K974432 ULTRAGUIDE 1000