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

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    K Number: K050843 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    265

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    Basic Information

    Device Name
    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
    K Number
    K050843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Xoft, Inc.
    Date Received
    April 1, 2005
    Decision Date
    December 22, 2005
    Product Code
    JAD
    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
    JAD System, Therapeutic, X-Ray

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    Other Clearances by Xoft, Inc.

    K Number Device Name
    K090914 AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
    K090417 AXXENT FLEXISHIELD MINI
    K083734 AXXENT SURFACE APPLICATOR, MODEL 710257
    K072616 AXXENT VAGINAL APPLICATOR
    K072683 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM