FDA UDI
In Commercial Distribution
🇺🇸 United States
Annalise Enterprise
DI: G140ANNALISEENTP30
·
Model: 3.3.0
·
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 Enterprise
- Primary DI
- G140ANNALISEENTP30
- Version / Model
- 3.3.0
- 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
- 2023-07-24
- Public Version
- 4
- Public Version Date
- 2026-02-16
- Public Version Status
- Update
- Public Device Record Key
- a57bab57-4c42-4002-b043-a659542e993a
Device 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.
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 |
|---|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Radiology | 892.2080 | 2 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | Radiology | 892.2080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G140ANNALISEENTP30 | HIBCC |
Customer Contacts
- Phone
- +611800958487
- [email protected]