FDA Registration
Active
🇺🇸 United States
CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)
Reg #: 1052701
·
FEI: 1000222289
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- OMEGA MEDICAL IMAGING, LLC
- Registration Number
- 1052701
- FEI Number
- 1000222289
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3400 St. Johns Parkway, Suite 1020
- City
- Sanford
- State
- FL
- ZIP
- 32771
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100102
Owner / Operator
- Firm Name
- OMEGA MEDICAL IMAGING, LLC
- Operator Number
- 9000656
- Address
- 3400 St. Johns Parkway, Suite 1020, --
- City
- Sanford
- State
- FL
- Postal Code
- 32771
- Country
- US
- Correspondent
- Matthew - Anderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2013-06-20 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2013-06-20 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2013-06-20 |
Proprietary Names
CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device