BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA)

    Reg #: 3009813196 · FEI: 3003873069 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Accuray Incorporated
    Registration Number
    3009813196
    FEI Number
    3003873069
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1240 Deming Way
    City
    Madison
    State
    WI
    ZIP
    53717
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121934

    Owner / Operator

    Firm Name
    Accuray Incorporated
    Operator Number
    9005157
    Address
    1209 Deming Way, --
    City
    Madison
    State
    WI
    Postal Code
    53717
    Country
    US
    Correspondent
    Daniel Biank

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    System, Planning, Radiation Therapy Treatment MUJ

    Proprietary Names

    TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility