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 ID: G140ANNALISECONTAINER60
• NIH Device Record Key: 7ffd85b9-1349-4eed-b14f-17f71b04297a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annalise Critical Care AI
• Version Model Number: CXR - 2.4+
• Catalog Number: Annalisecontainer6
• Company DUNS: 746802299
• Company Name: ANNALISE-AI PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai
• Phone: +611800958487
• Email: support@annalise.ai

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G140ANNALISECONTAINER60 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250831

FDA Product Code

• QAS: Radiological Computer-Assisted Triage And Notification Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by ANNALISE-AI PTY LTD

• G140ANNALISECONTAINER60 - Annalise Critical Care AI: 2025-08-05CXR 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 AI: 2025-08-05 CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligen
• G140ANNALISECONTAINER70 - Annalise Triage: 2025-07-10 software versions 2.3 Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI)
• G140ANNALISEENTP50 - Annalise Triage: 2024-01-19 Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize sugges
• G140ANNALISEENTP40 - Annalise Triage: 2023-11-14 Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize sugges
• G140ANNALISEENTP30 - Annalise Enterprise: 2023-08-01 Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize su
• G140ANNALISEENTP20 - Annalise Enterprise: 2023-06-16 Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize su