Identity
- Trade Name
- Annalise Triage FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- software versions 3.10+ 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. FDA UDI
- Model / Reference
- 3.10.0+ FDA UDI
- Description
- software versions 3.10+ 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. FDA UDI
Identifiers
- Catalog Number
- AnnaliseENTP6 FDA UDI
- Primary DI / UDI-DI
- G140ANNALISEENTP60 FDA UDI
- FDA Product Code
- QAS FDA UDIQFM FDA UDI
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application softwareX-ray image interpretive software
Annalise Triage by Annalise-Ai Pty , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Annalise-Ai Pty , Ltd.
Sources (1)
- FDA UDI dd5987db-29b1-4bd2-b969-7b3140fff1c8 35 fields · synced May 30, 2026