BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MRIdian A3i System

    Reg #: 3007546534 · FEI: 3007546534 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    VIEWRAY SYSTEMS, INC.
    Registration Number
    3007546534
    FEI Number
    3007546534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Thermo Fisher Way
    City
    Oakwood Village
    State
    OH
    ZIP
    44146
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212958

    Owner / Operator

    Firm Name
    Viewray Systems, Inc.
    Operator Number
    10090487
    Address
    2 Thermo Fisher Way
    City
    Oakwood Village
    State
    OH
    Postal Code
    44146
    Country
    US
    Correspondent
    Elizabeth R Osuna

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Accelerator, Linear, Medical IYE

    Proprietary Names

    MRIdian A3i System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device