Annalise Critical Care AI Annalisecontainer6

GUDID G140ANNALISECONTAINER60

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.

ANNALISE-AI PTY LTD

X-ray image interpretive software
Primary Device IDG140ANNALISECONTAINER60
NIH Device Record Key7ffd85b9-1349-4eed-b14f-17f71b04297a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnnalise Critical Care AI
Version Model NumberCXR - 2.4+
Catalog NumberAnnalisecontainer6
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG140ANNALISECONTAINER60 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QASRadiological Computer-Assisted Triage And Notification Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-05
Device Publish Date2025-07-28

Devices Manufactured by ANNALISE-AI PTY LTD

G140ANNALISECONTAINER60 - Annalise Critical Care AI2025-08-05CXR 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.
G140ANNALISECONTAINER60 - Annalise Critical Care AI2025-08-05 CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligen
G140ANNALISEENTP60 - Annalise Triage2025-08-01 software versions 3.10+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (A
G140ANNALISECONTAINER70 - Annalise Triage2025-07-10 software versions 2.3 Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI)
G140ANNALISEENTP50 - Annalise Triage2024-01-19 Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize sugges
G140ANNALISEENTP40 - Annalise Triage2023-11-14 Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize sugges
G140ANNALISEENTP30 - Annalise Enterprise2023-08-01 Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize su
G140ANNALISEENTP20 - Annalise Enterprise2023-06-16 Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize su
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