BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accuray Incorporated

    Reg #: 3003873069 · FEI: 3003873069 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Accuray Incorporated
    Registration Number
    3003873069
    FEI Number
    3003873069
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1209 DEMING WAY
    City
    MADISON
    State
    WI
    ZIP
    53717
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170788

    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
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    CyberKnife Treatment Delivery System CyberKnife S7 CyberKnife M6 TomoTherapy Treatment Delivery System with iDMS CyberKnife M6 Series (FM, FI, FI+, FIM, F Neuro) TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA) CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM Radixact Treatment Delivery System, Accuray Helix (A configuration of Radixact Treatment Delivery System) Accuray Stellar (A configuration of Radixact Treatment Delivery System) Adapt LTE Powered by Accuray Cenos Accuray Precision Treatment Planning System

    Establishment Types

    Manufacture Medical Device