BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Annalise Triage

    Reg #: 3023702863 · FEI: 3023702863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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
    K213941

    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 Triage Annalise Enterprise Annalise Critical Care AI Annalise Critical Care AI - Pneumothorax Annalise Triage CXR Annalise - Tension Pneumothorax Annalise - Pneumothorax Annalise Critical Care AI - Tension Pneumothorax Annalise Enterprise CXR Triage Pneumothorax Annalise Enterprise CXR Annalise Enterprise CXR Triage Annalise Critical Care AI - PTX Annalise Enterprise (US) Annalise - PTX Annalise Enterprise CXR Triage PTX

    Establishment Types

    Manufacture Medical Device