BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Annalise Enterprise CXR

    Reg #: 3023702863 · FEI: 3023702863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ANNALISE-AI
    Registration Number
    3023702863
    FEI Number
    3023702863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Level P, 24 Campbell Street
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K222268

    Owner / Operator

    Firm Name
    Annalise-AI
    Operator Number
    10085806
    Address
    Level P, 24 Campbell St
    City
    Sydney
    State
    New South Wales
    Postal Code
    2000
    Country
    AU

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Radiological Computer-Assisted Prioritization Software For Lesions QFM

    Proprietary Names

    Annalise Enterprise CXR Annalise Enterprise CXR Triage Annalise Enterprise (US) Annalise Enterprise CXR Triage Trauma Annalise Critical Care AI Annalise Critical Care AI - Vertebral Compression Fracture Annalise Triage Annalise Triage CXR Annalise - Vertebral Compression Fracture Annalise Critical Care AI - VCF Annalise - VCF Annalise Enterprise

    Establishment Types

    Manufacture Medical Device