Harrison-AI Medical Pty Ltd

FDA Device Registration & Listing · Sydney New South Wales, AU · Registration 3023702863

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023702863
FEI Number
3023702863
Entity Name
Harrison-AI Medical Pty Ltd
City/State/Country
Sydney New South Wales, AU
Establishment Address
Level P, 24 Campbell Street, Sydney New South Wales 2000, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Harrison-AI Medical Pty Ltd (Owner Number: 10085806)
Owner / Operator Contact Address
Level P, 24 Campbell St, Sydney, AU-NSW 2000, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222268
PMA Number
N/A

All Registered 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 Annalise Critical Care AI - Vasogenic Edema Annalise - Vasogenic Edema Comprehensive Care - Vasogenic Edema Annalise Triage - Vasogenic Edema Annalise Triage Annalise Enterprise CXR Triage Pneumothorax Annalise Triage CXR Annalise - PTX Annalise Triage Annalise - Tension Pneumothorax Annalise Enterprise CXR Annalise Critical Care AI - PTX Annalise Enterprise CXR Triage PTX Annalise Enterprise Annalise Enterprise (US) Annalise Enterprise CXR Triage Annalise Critical Care AI Annalise Critical Care AI - Pneumothorax Annalise Critical Care AI - Tension Pneumothorax Annalise - Pneumothorax Annalise Triage CTB Annalise Triage - Mass Effect Annalise Critical Care AI Annalise Triage Annalise - Mass Effect Annalise Critical Care AI - Mass Effect Comprehensive Care Comprehensive Care - Mass Effect Comprehensive Care - CTB Comprehensive Care Annalise Triage CTB Annalise Enterprise (US) Annalise Enterprise Annalise Critical Care AI - ICH Annalise Enterprise CTB Annalise Enterprise CTB Triage Trauma Annalise Critical Care AI Annalise Enterprise CTB Triage Annalise Triage Annalise Enterprise CTB Triage Trauma - ICH Comprehensive Care - ICH Comprehensive Care - Intracranial Hemorrhage Comprehensive Care - CTB Annalise - ICH Annalise Enterprise CXR Triage Annalise Enterprise CXR Annalise Enterprise Annalise Enterprise CXR Triage Trauma Annalise Enterprise (US) Annalise Triage Annalise Critical Care AI - Vertebral Compression Fracture Annalise Triage CXR Annalise - VCF Annalise Critical Care AI - VCF Annalise - Vertebral Compression Fracture Annalise Critical Care AI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2023-05-31
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2023-05-31
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2023-11-05
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2022-08-16
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2023-11-05
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2023-07-20
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2023-05-31

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Harrison-AI Medical Pty Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220709 Aidoc Medical , Ltd. BriefCase 2022-10-07
K190362 Zebra Medical Vision, Ltd. HealthPNX 2019-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023702863. Last updated year: 2026. Please use registration number 3023702863 when referencing this establishment in official correspondence.
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