FDA Registration
Active
🇦🇺 Australia
Annalise Triage
Reg #: 3023702863
·
FEI: 3023702863
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ANNALISE-AI
- Registration Number
- 3023702863
- FEI Number
- 3023702863
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Level P, 24 Campbell Street
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K231094
Owner / Operator
- Firm Name
- Annalise-AI
- Operator Number
- 10085806
- Address
- Level P, 24 Campbell St
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2000
- Country
- AU
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | Class 2 | Radiology | No | 2023-11-05 |
Proprietary Names
Annalise Triage
Annalise Triage OHCP
Annalise Critical Care AI
Annalise - OH
Annalise Critical Care AI - OH
Annalise Triage CTB
Annalise - Obstructive Hydrocephalus
Annalise Enterprise CTB Triage Trauma - OH
Annalise Critical Care AI - Obstructive Hydrocephalus
Annalise Triage OH
Establishment Types
Manufacture Medical Device