Data / Medical devices / Australia / Harrison-AI Medical Pty Ltd

Harrison-AI Medical Pty Ltd: FDA-registered device maker in Sydney New South Wales, Australia, 9 510(k) clearances

Name: Harrison-AI Medical Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Harrison-AI Medical Pty Ltd is registered with the FDA (registration 3023702863) in Sydney New South Wales, Australia. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3023702863
Address: Level P, 24 Campbell Street, Sydney New South Wales, Australia, 2000
Owner or operator: Harrison-AI Medical Pty Ltd (10085806)
Roles: Manufacturer
First device listed: August 16, 2022
Registered through: 2026
Brand names listed: Annalise - ICH, Annalise - Mass Effect, Annalise - OH, Annalise - Obstructive Hydrocephalus, Annalise - PTX, Annalise - Pleural Effusion, Annalise - Pneumoperitoneum, Annalise - Pneumothorax and more

Devices it lists

Device	Product code	Class	Role	Source
Radiological Computer-Assisted Prioritization Software For Lesions	QFM	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 3, 2026	K253818	Annalise Enterprise	QAS	Substantially Equivalent	Harrison-AI Medical Pty, Ltd.	accessdata.fda.gov
April 23, 2025	K250831	Annalise Enterprise	QFM	Substantially Equivalent	Annalise-Ai	accessdata.fda.gov
September 22, 2023	K231767	Annalise Enterprise CTB Triage Trauma	QAS	Substantially Equivalent	Annalise-Ai Pty , Ltd.	accessdata.fda.gov
September 22, 2023	K231384	Annalise Enterprise CTB Triage Trauma	QAS	Substantially Equivalent	Annalise-Ai Pty , Ltd.	accessdata.fda.gov
August 15, 2023	K231094	Annalise Enterprise CTB Triage-OH	QAS	Substantially Equivalent	Annalise-Ai Pty , Ltd.	accessdata.fda.gov
April 3, 2023	K223240	Annalise Enterprise CTB Triage Trauma	QAS	Substantially Equivalent	Annalise-Ai Pty , Ltd.	accessdata.fda.gov
March 28, 2023	K222268	Annalise Enterprise CXR Triage Trauma	QFM	Substantially Equivalent	Annalise-Ai Pty , Ltd.	accessdata.fda.gov
March 28, 2023	K222179	Annalise Enterprise CXR Triage Trauma	QFM	Substantially Equivalent	Annalise-Ai Pty , Ltd.	accessdata.fda.gov
February 24, 2022	K213941	Annalise Enterprise CXR Triage Pneumothorax	QFM	Substantially Equivalent	Annalise-Ai	accessdata.fda.gov

Compare with other makers

Updated March 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.