BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Blue Phantom PT

    Reg #: 1062572 · FEI: 3001238439 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IBA Dosimetry America
    Registration Number
    1062572
    FEI Number
    3001238439
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    470 Springpark Place, Suite #700
    City
    Herndon
    State
    VA
    ZIP
    20170
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191821

    Owner / Operator

    Firm Name
    IBA Dosimetry GmbH
    Operator Number
    9011908
    Address
    BAHNHOFSTRASSE 5, --
    City
    SCHWARZENBRUCK
    State
    Bavaria
    Postal Code
    D-90592
    Country
    DE

    Products

    Device Name Product Code
    System, Radiation Therapy, Charged-Particle, Medical LHN

    Proprietary Names

    Blue Phantom PT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198