BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)

    Reg #: 3017102960 · FEI: 3017102960 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
    Registration Number
    3017102960
    FEI Number
    3017102960
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite L1.108, 477 Pitt Street
    City
    Haymarket New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K203518

    Owner / Operator

    Firm Name
    Omniscient Neurotechnology Pty Ltd (o8t)
    Operator Number
    10080969
    Address
    Suite L1.108, 477 Pitt Street
    City
    Haymarket
    State
    New South Wales
    Postal Code
    2000
    Country
    AU
    Correspondent
    Arie Henkin

    US Agent

    Business Name
    OMNISCIENT NEUROTECHNOLOGY AMERICA LTD
    Contact Name
    Curt Thomas
    Address
    4023 Kennett Pike Pmb 50360
    City
    Wilmington
    State
    DE
    ZIP
    19807
    Country
    US
    Email
    [email protected]
    Phone
    302 7253571

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Quicktome Quicktome Software Suite

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198