Annalise Enterprise
GUDID G140ANNALISEENTP20
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 Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software| Primary Device ID | G140ANNALISEENTP20 |
| NIH Device Record Key | 0e77a68c-2aba-4fa8-a662-7a959292fec0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Annalise Enterprise |
| Version Model Number | 3.2.0 |
| 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 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai | |
| Phone | +611800958487 |
| support@annalise.ai |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G140ANNALISEENTP20 [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 | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
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 |
Trademark Results [Annalise Enterprise]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANNALISE ENTERPRISE 79338512 not registered Live/Pending |
Annalise-AI Pty Ltd 2022-03-02 |
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