FDA UDI
In Commercial Distribution
🇺🇸 United States
Annalise Triage
DI: G140ANNALISEENTP50
·
Model: 3.6.0+
·
HARRISON-AI MEDICAL PTY LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Annalise Triage
- Primary DI
- G140ANNALISEENTP50
- Version / Model
- 3.6.0+
- Catalog Number
- AnnaliseENTP5
- Company Name
- HARRISON-AI MEDICAL PTY LTD
- Labeler DUNS
- 746802299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-11
- Public Version
- 7
- Public Version Date
- 2026-02-16
- Public Version Status
- Update
- Public Device Record Key
- 73952dfc-93d8-4eab-be28-b1b8be256e65
Device Description
software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0 Annalise Triage (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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | Radiology | 892.2080 | 2 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Radiology | 892.2080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63386 | X-ray image interpretive software | An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G140ANNALISEENTP50 | HIBCC |
Customer Contacts
- Phone
- +611800958487
- [email protected]