BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Harrison-AI Medical Pty Ltd

    Reg #: 3023702863 · FEI: 3023702863 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    61
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Harrison-AI Medical Pty Ltd
    Registration Number
    3023702863
    FEI Number
    3023702863
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Level P, 24 Campbell Street
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K222179

    Owner / Operator

    Firm Name
    Harrison-AI Medical Pty Ltd
    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 Triage And Notification Software QAS
    Radiological Computer-Assisted Prioritization Software For Lesions QFM

    Proprietary Names

    Annalise Triage Annalise Enterprise CXR Triage Trauma Annalise Critical Care AI - Pneumoperitoneum Annalise - Pneumoperitoneum Annalise Critical Care AI - Pleural Effusion Annalise Critical Care AI Annalise Enterprise (US) Annalise Enterprise CXR Annalise Triage CXR Annalise Enterprise CXR Triage Annalise Enterprise Annalise - Pleural Effusion Comprehensive Care Comprehensive Care - CTB Annalise Triage CTB Annalise Critical Care AI - Vasogenic Edema Annalise - Vasogenic Edema Comprehensive Care - Vasogenic Edema Annalise Triage - Vasogenic Edema Annalise Enterprise CXR Triage Pneumothorax Annalise - PTX Annalise - Tension Pneumothorax Annalise Critical Care AI - PTX Annalise Enterprise CXR Triage PTX Annalise Critical Care AI - Pneumothorax Annalise Critical Care AI - Tension Pneumothorax Annalise - Pneumothorax Annalise Triage - Mass Effect Annalise - Mass Effect Annalise Critical Care AI - Mass Effect Comprehensive Care - Mass Effect Annalise Critical Care AI - ICH Annalise Enterprise CTB Annalise Enterprise CTB Triage Trauma Annalise Enterprise CTB Triage Annalise Enterprise CTB Triage Trauma - ICH Comprehensive Care - ICH Comprehensive Care - Intracranial Hemorrhage Annalise - ICH Annalise Critical Care AI - Vertebral Compression Fracture Annalise - VCF Annalise Critical Care AI - VCF Annalise - Vertebral Compression Fracture Comprehensive Care - CXR Comprehensive Care - Pneumothorax Comprehensive Care - Vertebral Compression Fracture Comprehensive Care - PTX Comprehensive Care - Tension Pneumothorax Comprehensive Care - Pneumoperitoneum Comprehensive Care - Pleural Effusion Comprehensive Care - VCF Comprehensive Care - Obstructive Hydrocephalus Annalise Triage OHCP Annalise Enterprise CTB Triage Trauma - OH Annalise - OH Annalise Critical Care AI - Obstructive Hydrocephalus Annalise Critical Care AI - OH Comprehensive Care - OH Annalise Triage OH Annalise - Obstructive Hydrocephalus Comprehensive Care - Acute Infarct

    Establishment Types

    Manufacture Medical Device