FDA Registration
Active
🇺🇸 United States
TrackX
Reg #: 3014391847
·
FEI: 3014391847
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- TRACKX TECHNOLOGY Inc.
- Registration Number
- 3014391847
- FEI Number
- 3014391847
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 437 Mills Dimmocks Road, Suite 28
- City
- Hillsborough
- State
- NC
- ZIP
- 27278
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200360
Owner / Operator
- Firm Name
- TrackX Technology Inc.
- Operator Number
- 10057101
- Address
- 437 Dimmocks Mill Road, Suite 28
- City
- Hillsborough
- State
- NC
- Postal Code
- 27278
- Country
- US
- Correspondent
- David Skwerer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2020-05-28 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2020-05-28 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-05-28 |
Proprietary Names
TrackX
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility