Annalise Triage

GUDID G140ANNALISEENTP40

Annalise Triage 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 ID: G140ANNALISEENTP40
• NIH Device Record Key: 5e57a20c-87ba-48c5-a65a-78b92c0d099c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annalise Triage
• Version Model Number: 3.4.1
• 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
• 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
• 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	G140ANNALISEENTP40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213941

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: 2023-11-14
• Device Publish Date: 2023-11-06

On-Brand Devices [Annalise Triage]

• G140ANNALISEENTP40: Annalise Triage is a medical device software application which uses artificial intelligence (AI)
• G140ANNALISEENTP50: Annalise Triage is a medical device software application which uses artificial intelligence (AI)