Annalise Triage Annalisecontainer7

GUDID G140ANNALISECONTAINER70

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.

ANNALISE-AI PTY LTD

Radiology DICOM image processing application software
Primary Device IDG140ANNALISECONTAINER70
NIH Device Record Key1b0e4097-ccdc-4189-9d89-c2f3081074fc
Commercial Distribution Discontinuation2025-07-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnnalise Triage
Version Model Number2.3+
Catalog NumberAnnalisecontainer7
Company DUNS746802299
Company NameANNALISE-AI PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai
Phone+611800958487
Emailsupport@annalise.ai

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG140ANNALISECONTAINER70 [Primary]

FDA Product Code

QASRadiological Computer-Assisted Triage And Notification Software
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

On-Brand Devices [Annalise Triage]

G140ANNALISEENTP40Annalise Triage is a medical device software application which uses artificial intelligence (AI)
G140ANNALISEENTP50Annalise Triage is a medical device software application which uses artificial intelligence (AI)
G140ANNALISECONTAINER70software versions 2.3 Annalise Critical Care AI is a medical device software application which u
G140ANNALISEENTP60software versions 3.10+ Annalise Critical Care AI is a medical device software application which

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