FDA Registration
Active
🇺🇸 United States
Insight Agile DRF
Reg #: 3015437189
·
FEI: 3015437189
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- IMAGING ENGINEERING, LLC
- Registration Number
- 3015437189
- FEI Number
- 3015437189
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4424 NW 13th Street, Suite B-12
- City
- Gainesville
- State
- FL
- ZIP
- 32609
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210469
Owner / Operator
- Firm Name
- Imaging Engineering, LLC
- Operator Number
- 10060138
- Address
- 4424 NW 13th Street, Suite B-12
- City
- Gainesville
- State
- FL
- Postal Code
- 32609
- Country
- US
- Correspondent
- george Jachode
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2021-12-03 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2021-12-03 |
| Solid State Fluoroscopic X-Ray Imager | QHY | Class 2 | Radiology | No | 2021-12-03 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2021-12-03 |
| C-Arm Fluoroscopic X-Ray System | RCC | Class 2 | Radiology | No | 2021-12-03 |
Proprietary Names
Insight Agile DRF
Establishment Types
Manufacture Medical Device