FDA Registration
Active
🇺🇸 United States
ORTHOSCAN, INC.
Reg #: 3005254598
·
FEI: 3005254598
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ORTHOSCAN, INC.
- Registration Number
- 3005254598
- FEI Number
- 3005254598
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14555 N. 82nd Street
- City
- SCOTTSDALE
- State
- AZ
- ZIP
- 85260
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133174
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 | 2014-08-04 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2014-08-04 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2010-11-22 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2023-06-22 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2026-01-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2026-01-20 |
Proprietary Names
OrthoScan FD Mini C-arm
OrthoScan EMR Image Link
TAU Model 1000-0015 Mini C-arm
TAU Model 1000-0016 Mini C-arm
TAU Model 1000-0017 Mini C-arm
OrthoScan Mobile DI
TAU Model 1000-0016 Mini C-Arm
TAU Model 1000-0017 Mini C-Arm
TAU Model 1000-0015 Mini C-Arm
Orthoscan TAU Mini C-arm
OrthoScan HD
Orthoscan VERSA Mini C-Arm
Orthoscan TAU MVP Mini C-arm System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device