BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    THERATRON EQUINOX, MODELS 80 CM AND 100 CM

    K Number: K053485 · Decision Mar 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    THERATRON EQUINOX, MODELS 80 CM AND 100 CM
    K Number
    K053485
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mds Nordion, Inc.
    Date Received
    December 15, 2005
    Decision Date
    March 9, 2006
    Product Code
    IWB
    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
    IWB System, Radiation Therapy, Radionuclide

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