FDA Registration
Active
🇺🇸 United States
TRON
Reg #: 3004198450
·
FEI: 3004198450
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- Xoran Technologies, LLC
- Registration Number
- 3004198450
- FEI Number
- 3004198450
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5210 South State Road
- City
- Ann Arbor
- State
- MI
- ZIP
- 48108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221230
Owner / Operator
- Firm Name
- Xoran Technologies LLC
- Operator Number
- 10028111
- Address
- 5210 South State Street
- City
- Ann Arbor
- State
- MI
- Postal Code
- 48108
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2022-08-12 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-08-12 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2022-08-12 |
Proprietary Names
TRON
Establishment Types
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device