BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reflexion X1

    Reg #: 3011716550 · FEI: 3011716550 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    REFLEXION MEDICAL, INC.
    Registration Number
    3011716550
    FEI Number
    3011716550
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25881 Industrial Blvd
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190978

    Owner / Operator

    Firm Name
    RefleXion Medical, Inc.
    Operator Number
    10078251
    Address
    25841 Industrial Blvd, Suite 275
    City
    Hayward
    State
    CA
    Postal Code
    94545
    Country
    US
    Correspondent
    Leena Kadakia

    Products

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

    Proprietary Names

    Reflexion X1 RefleXion Medical Radiotherapy System RXM1000

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198