FDA Registration
Active
🇦🇺 Australia
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
Reg #: 3017058304
·
FEI: 3017058304
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
- Registration Number
- 3017058304
- FEI Number
- 3017058304
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lvl 1, 94 Mallett Street
- City
- Camperdown New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K231929
Owner / Operator
- Firm Name
- Sydney Neuroimaging Analysis Centre PTY LTD
- Operator Number
- 10075724
- Address
- Lvl 1, 94 Mallett Street
- City
- Camperdown
- State
- New South Wales
- Postal Code
- 2050
- Country
- AU
- Correspondent
- Chenyu Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2020-06-25 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-12-19 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-12-19 |
Proprietary Names
Torana Medical Imaging Gateway
iQ-Solutions
Establishment Types
Manufacture Medical Device