BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Elements Segmentation CMF

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    18
    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
    K113732

    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, Image Processing, Radiological LLZ
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Elements Segmentation CMF Elements Lead Localization Elements Segmentation Cranial Elements Segmentation Thoracic & Spine Elements SmartBrush Elements Object Manipulation Elements Segmentation Basal Ganglia Elements Trajectory Planning Elements Segmentation Pelvic Elements Segmentation Head & Neck Elements Anatomical Mapping Elements SmartBrush Angio Elements Segmentation Spine Elements Fibertracking RT Elements SmartBrush Spine SRS Elements Fibertracking iPlan iPlan CMF

    Establishment Types

    Manufacture Medical Device