FDA Registration
Active
🇦🇺 Australia
SEE-MODE TECHNOLOGIES PTY LTD
Reg #: 3042248552
·
FEI: 3042248552
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SEE-MODE TECHNOLOGIES PTY LTD
- Registration Number
- 3042248552
- FEI Number
- 3042248552
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3/162 Collins St
- City
- Melbourne Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K240697
Owner / Operator
- Firm Name
- See-Mode Technologies Pty Ltd
- Operator Number
- 10082266
- Address
- 3/162 Collins St
- City
- Melbourne
- State
- Victoria
- Postal Code
- 3000
- Country
- AU
- Correspondent
- Sadaf Monajemi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-10-08 |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | Class 2 | Radiology | No | 2024-10-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-07-08 |
Proprietary Names
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
AVA (Augmented Vascular Analysis)
Establishment Types
Manufacture Medical Device