Annalise Critical Care AI

Basic Information

• Brand Name: Annalise Critical Care AI
• Primary DI: G140ANNALISECONTAINER60
• Version / Model: CXR - 2.4+
• Catalog Number: Annalisecontainer6
• Company Name: HARRISON-AI MEDICAL PTY LTD
• Labeler DUNS: 746802299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-28
• Public Version: 2
• Public Version Date: 2026-02-16
• Public Version Status: Update
• Public Device Record Key: 7ffd85b9-1349-4eed-b14f-17f71b04297a

Device Description

CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	892.2080	2
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	892.2080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63386	X-ray image interpretive software	An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G140ANNALISECONTAINER60	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250831	000