FDA Registration
Active
🇺🇸 United States
Turner Imaging Systems, Inc.
Reg #: 3013099020
·
FEI: 3013099020
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Turner Imaging Systems, Inc.
- Registration Number
- 3013099020
- FEI Number
- 3013099020
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1119 S 1680 W
- City
- Orem
- State
- UT
- ZIP
- 84058
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190024
Owner / Operator
- Firm Name
- Turner Imaging Systems
- Operator Number
- 10061743
- Address
- 1119 S 1680 W
- City
- Orem
- State
- UT
- Postal Code
- 84058
- 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 | 2019-11-15 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2019-11-15 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2026-04-24 |
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2025-11-18 |
Proprietary Names
Smart-C
Lumos 3DX
KyphoLift
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)