BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IBA Dosimetry GmbH

    Reg #: 9614952 · FEI: 3006653576 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    38
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    IBA Dosimetry GmbH
    Registration Number
    9614952
    FEI Number
    3006653576
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bahnhofstrasse 5
    City
    SCHWARZENBRUCK Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K032594

    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
    System, Radiation Therapy, Charged-Particle, Medical LHN
    Medical Device Data System OUG
    Instrument, Quality-Assurance, Radiologic LHO
    Accessory - Film Dosimetry System MWW
    Phantom, Anthropomorphic, Radiographic IXG

    Proprietary Names

    ONE DIMENSIONAL WATER PHANTOM, WP 1D DPD-3 myQA iON Dose 1 with different Ionization chambers (e.g. FC65-P, PPC40) OmniPro Incline incl MLIC Zebra, Giraffe DPD-12PC incl 2D Detector Arrays: Transmission Detector Dolphin, I'mRT MatriXX and MatriXX Evolution Compass myQA Cockpit RFA-300 UTILITY LDA-99 SC incl electometer emXX Sphinx Compact, myQA Phoenix SMfit KermaX myQA Daily, DOSE-X QA Crosschecker, myQA StarTrack3 MagicMax / MagicMax Universal with different detectors, Dosimax with different detectors, OmniPro Advance with StarTrack myQA Machines with StarTrack, myQA FastTrack, Sphinx, myQA FastTrack PT RFA A-300 myQA Accept including accessories: Lift Table, Water reservoir, myQA Quicklevel Blue Phantom 2, myQA Blue Phantom 3 Blue Phantom Helix, Blue Phantom Compact, Blue Phantom SmartScan Stealth Chamber, CC04, CC08, CC-13S, CC13, CC25, FC23-C, with different detectors: Semiconductor detectors and chambers: NACP, CC13, FC65-P, FC65-G, PPC05, PPC40 Razor Chamber, Razor Nanochamber, Razor Detector, incl Water Phantom, MatriXX PT and Software DigiPhant PT Blue Phantom PT OMNIPRO I'MRT System: SW OmniPro I'mRT, myQA Patients with myQA FastTrack Hardware: I'mRT Phantom, Film Scanners, I'mRT MatriXX, MatriXX Evolution, Matrixx FFF, MatriXX One MatriXX Resolution, MatriXX Air, myQA SRS miniPhantom, miniPhantom R MultiCube, Universal ImRT Phantom Solid Phantoms (SP22, SP33, SP34)

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)