BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MatriXX Resolution, MatriXX Air, myQA SRS

    Reg #: 9614952 · FEI: 3006653576 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IBA Dosimetry GmbH
    Registration Number
    9614952
    FEI Number
    3006653576
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bahnhofstrasse 5
    City
    SCHWARZENBRUCK Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K031634

    Owner / Operator

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

    US Agent

    Business Name
    IBA Dosimetry America, Inc.
    Contact Name
    Nick Narloch
    Address
    470 SPRINGPARK PLACE, SUITE #700
    City
    Herndon
    State
    VA
    ZIP
    20170
    Country
    US
    Email
    [email protected]
    Phone
    901 8055767

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    MatriXX Resolution, MatriXX Air, myQA SRS OMNIPRO I'MRT Hardware: I'mRT Phantom, Film Scanners, I'mRT MatriXX, MatriXX Evolution, Matrixx FFF, MatriXX One System: SW OmniPro I'mRT, myQA Patients with myQA FastTrack

    Establishment Types

    Manufacture Medical Device