FDA Registration
Active
🇺🇸 United States
Orthoscan TAU Mini C-arm
Reg #: 3005254598
·
FEI: 3005254598
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ORTHOSCAN, INC.
- Registration Number
- 3005254598
- FEI Number
- 3005254598
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14555 N. 82nd Street
- City
- SCOTTSDALE
- State
- AZ
- ZIP
- 85260
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250587
Owner / Operator
- Firm Name
- Ziehm-Orthoscan INC.
- Operator Number
- 9073005
- Address
- 14555 N. 82nd Street
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85260
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2025-07-10 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2025-07-10 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-07-10 |
Proprietary Names
Orthoscan TAU Mini C-arm
Establishment Types
Manufacture Medical Device