BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    (Elements) RT Planning Platform

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BRAINLAB AG
    Registration Number
    8043933
    FEI Number
    3002619595
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Olof-Palme-Strasse 9
    City
    Munich Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K250440

    Owner / Operator

    Firm Name
    Brainlab AG
    Operator Number
    9004547
    Address
    Olof-Palme-Strasse 9
    City
    Munich
    State
    Bavaria
    Postal Code
    81829
    Country
    DE

    US Agent

    Business Name
    BRAINLAB, INC.
    Contact Name
    Paul Neil
    Address
    5 Westbrook Corporate Ctr Ste 1000
    City
    WESTCHESTER
    State
    IL
    ZIP
    60154
    Country
    US
    Email
    [email protected]
    Phone
    708 4091343

    Products

    Device Name Product Code
    System, Planning, Radiation Therapy Treatment MUJ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    (Elements) RT Planning Platform (Elements) Dose Review Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT Elements SmartBrush [Angio, Spine] RT (Elements) Retreatment Review Elements Object Management RT (Elements) Cranial SRS; (Elements) Spine SRS Elements AI Tumor Segmentation RT (Elements) Multiple Brain Mets SRS RT Elements 4.5 (Elements) Cranial SRS w/ Cones

    Establishment Types

    Manufacture Medical Device