Annalise Enterprise

GUDID G140ANNALISEENTP30

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.

ANNALISE-AI PTY LTD

Radiology DICOM image processing application software

• Primary Device ID: G140ANNALISEENTP30
• NIH Device Record Key: a57bab57-4c42-4002-b043-a659542e993a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annalise Enterprise
• Version Model Number: 3.3.0
• 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	G140ANNALISEENTP30 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213941

FDA Product Code

• QFM: Radiological Computer-Assisted Prioritization Software For Lesions

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: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [Annalise Enterprise]

• G140ANNALISEENTP20: Annalise Enterprise is a medical device software application which uses artificial intelligence
• G140ANNALISEENTP30: Annalise Enterprise is a medical device software application which uses artificial intelligence