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

    AUTIMO 2.5-D AND AUTIMO 3-D

    K Number: K972016 · Decision Dec 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    4
    Review Days
    188

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    Basic Information

    Device Name
    AUTIMO 2.5-D AND AUTIMO 3-D
    K Number
    K972016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.L. Mcintosh & Assoc., Inc.
    Date Received
    May 30, 1997
    Decision Date
    December 4, 1997
    Product Code
    IXI
    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
    IXI Block, Beam-Shaping, Radiation Therapy

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