FDA.reportPublic FDA data

Annalise Enterprise

Primary DI
G140ANNALISEENTP30
Brand
Annalise Enterprise
Company
HARRISON-AI MEDICAL PTY LTD
Model
3.3.0
Device description
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.
Published
2023-07-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213941000Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai2022-02-24QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G140ANNALISEENTP30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

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
G140ANNALISEENTP60Annalise Triage3.10.0+AnnaliseENTP62025-07-24
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
G140ANNALISEENTP20Annalise Enterprise3.2.02023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
B720BX360TRIAGELVO1430Triage LVOBRAINOMIX LIMITEDQAS2026-05-06
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
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-24
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-24
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