FDA.reportPublic FDA data

Harrison-AI Medical Pty Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30237028633023702863Harrison-AI Medical Pty Ltd1N2026-01-01Level P, 24 Campbell Street Sydney New South Wales AU 2000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
G140ANNALISECONTAINER60Annalise Critical Care AI - (Manufactured under the former company name: Annalise-AI Pty Ltd) 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.+611800958487support@annalise.ai
G140ANNALISECONTAINER70Annalise Triage - (Manufactured under the former company name: Annalise-AI Pty Ltd) CTB software versions 2.3+ 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.+611800958487support@annalise.ai
G140ANNALISEENTP20Annalise Enterprise - (Manufactured under the former company name: Annalise-AI Pty Ltd) Annalise Enterprise 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.+611800958487support@annalise.ai
G140ANNALISEENTP30Annalise Enterprise - (Manufactured under the former company name: Annalise-AI Pty Ltd) Annalise Enterprise 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.+611800958487support@annalise.ai
G140ANNALISEENTP40Annalise Triage - (Manufactured under the former company name: Annalise-AI Pty Ltd) Annalise Triage 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.+611800958487support@annalise.ai
G140ANNALISEENTP50Annalise Triage - (Manufactured under the former company name: Annalise-AI Pty Ltd) software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0 Annalise Triage (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.+611800958487support@annalise.ai
G140ANNALISEENTP60Annalise Triage - (Manufactured under the former company name: Annalise-AI Pty Ltd) software versions 3.10+ 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.+611800958487support@annalise.ai

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3082571594966928K253818Annalise EnterpriseQAS2026-03-03
3082571536311127K250831Annalise EnterpriseQFM2025-04-23
3082571481545197K231767Annalise Enterprise CTB Triage TraumaQAS2023-09-22
3082571301768396K231384Annalise Enterprise CTB Triage TraumaQAS2023-09-22
3082571073212620K231094Annalise Enterprise CTB Triage-OHQAS2023-08-15
3082571429007405K223240Annalise Enterprise CTB Triage TraumaQAS2023-04-03
3082571261184242K222268Annalise Enterprise CXR Triage TraumaQFM2023-03-28
3082571464748733K222179Annalise Enterprise CXR Triage TraumaQFM2023-03-28
3082571089338894K213941Annalise Enterprise CXR Triage PneumothoraxQFM2022-02-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QAS52026-03-03
QFM42025-04-23

GUDID#