← Back to catalogue
Annalise Enterprise
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref AnnaliseENTP3Model Annalise Enterprise
Identity
- Trade Name
- Annalise Enterprise EUDAMEDFDA 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
- Annalise Enterprise EUDAMEDAnnaliseENTP3 EUDAMED3.3.0 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
- G140ANNALISEENTP30 EUDAMEDFDA UDI
- Basic UDI-DI
- ++G140AnnaliseEnterprisEM EUDAMED
- FDA Product Code
- QFM FDA UDIQAS FDA UDI
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2080 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Annalise Enterprise by Harrison-AI Medical Pty Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253818 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K250831 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++G140AnnaliseEnterprisEM | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Harrison-AI Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000010247
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (3)
- EUDAMED 7fbb5ab9-4418-47ff-aaf3-2f00874dadfc 61 fields · synced Jul 17, 2026
- FDA UDI a57bab57-4c42-4002-b043-a659542e993a 34 fields · synced May 30, 2026
- FDA 510(k) K253818 1 fields · synced May 18, 2026