FDA Registration
Active
🇦🇺 Australia
Optimized Positioning System (OPS) Insight
Reg #: 3012916784
·
FEI: 3012916784
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OPTIMIZED ORTHO PTY LTD
- Registration Number
- 3012916784
- FEI Number
- 3012916784
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17 Bridge Street
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K202805
Owner / Operator
- Firm Name
- Optimized Ortho Pty Ltd
- Operator Number
- 10052254
- Address
- 17 Bridge Street
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2073
- Country
- AU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-03-02 |
Proprietary Names
Optimized Positioning System (OPS) Insight
Establishment Types
Manufacture Medical Device