Identity
- Trade Name
- Annalise Enterprise FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3.2.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G140ANNALISEENTP20 FDA UDI
- FDA Product Code
- QFM FDA UDIQAS FDA UDI
- GMDN Term
- Radiology DICOM image processing application 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 software
Annalise Enterprise 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 0e77a68c-2aba-4fa8-a662-7a959292fec0 34 fields · synced May 30, 2026