BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    4DMEDICAL LIMITED

    Reg #: 3017426576 · FEI: 3017426576 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    4DMEDICAL LIMITED
    Registration Number
    3017426576
    FEI Number
    3017426576
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Level 7 Melbourne Connect, 700 Swanston Street
    City
    Carlton Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K241847

    Owner / Operator

    Firm Name
    4DMedical Limited
    Operator Number
    10077775
    Address
    Level 7,, 700 Swanston street
    City
    Carlton
    State
    Victoria
    Postal Code
    3053
    Country
    AU

    US Agent

    Business Name
    4DMedical
    Contact Name
    Andreas Fouras
    Address
    21255 Burbank Blvd, Suite 120
    City
    Woodland Hills
    State
    CA
    ZIP
    91367
    Country
    US
    Email
    [email protected]
    Phone
    818 4031151

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, X-Ray, Tomography, Computed JAK
    System, Image Processing, Radiological LLZ
    Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. QWO

    Proprietary Names

    PHA 4 RV/LV Software Imbio CAC Software CT Lung Ventilation Analysis Software CT:V CT LVAS CT:VQ XV LVAS XV Lung Ventilation Analysis Software System Imbio Segmentation Editing Tool: Imbio SET LDA Lung Density Analysis IQ - UIP

    Establishment Types

    Manufacture Medical Device