FDA.reportPublic FDA data

Annalise Triage

Primary DI
G140ANNALISEENTP60
Brand
Annalise Triage
Company
HARRISON-AI MEDICAL PTY LTD
Model
3.10.0+
Catalog number
AnnaliseENTP6
Device description
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.
Published
2025-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QASRadiological Computer-Assisted Triage And Notification Software
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology2
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G140ANNALISEENTP60PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn 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].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+611800958487support@annalise.ai

Regulatory Flags#

DUNS number
746802299
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G140ANNALISECONTAINER60Annalise Critical Care AICXR - 2.4+Annalisecontainer62025-07-28
G140ANNALISECONTAINER70Annalise Triage2.3+Annalisecontainer72025-07-02
G140ANNALISEENTP50Annalise Triage3.6.0+AnnaliseENTP52024-01-11
G140ANNALISEENTP40Annalise Triage3.4.12023-11-06
G140ANNALISEENTP30Annalise Enterprise3.3.02023-07-24
G140ANNALISEENTP20Annalise Enterprise3.2.02023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
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B720BX360TRIAGESTRO1430Triage StrokeBRAINOMIX LIMITEDQAS2026-05-06
00199874323862NeuroICHNEUROCAREAI INCQAS2026-04-24
08800066200589JLK-ICHJLK, Inc.QAS2026-03-25
08800066200596JLK-LVOJLK, Inc.QAS2026-03-25
08800066200602JLK-SDHJLK, Inc.QAS2026-03-25
07290018052365BriefCase TriageAIDOC MEDICAL LTDQAS2026-02-15
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
B720BX360TRIAGESTRO142Triage StrokeBRAINOMIX LIMITEDQAS2026-02-03
B720BX360TRIAGESTRO141Triage StrokeBRAINOMIX LIMITEDQAS2025-11-28
04056869959023syngo.CT Brain HemorrhageSiemens Healthcare GmbHQAS2025-11-21
04056869967844Update Label 127046Siemens Healthcare GmbHQAS2025-11-21
B720BX360TRIAGELVO1410Triage LVOBRAINOMIX LIMITEDQAS2025-10-16
B720BX360TRIAGEICH1120Triage ICHBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGELVO1120Triage LVOBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGEICH1400Triage ICHBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGELVO1400Triage LVOBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGESTRO1400Triage StrokeBRAINOMIX LIMITEDQAS2025-08-18
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQFM2025-07-28
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQAS2025-07-28
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-02
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-02
M722X25122P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XC25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XD25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
B761R60Rapid Ischemaview, Inc.QAS2025-05-07
B761R60Rapid Ischemaview, Inc.QFM2025-05-07
03770024774016SmartChestMILVUEQFM2025-03-31
M722X25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27