FDA Registration
Active
🇺🇸 United States
OMEGA MEDICAL IMAGING, LLC
Reg #: 1052701
·
FEI: 1000222289
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- OMEGA MEDICAL IMAGING, LLC
- Registration Number
- 1052701
- FEI Number
- 1000222289
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3400 St. Johns Parkway, Suite 1020
- City
- Sanford
- State
- FL
- ZIP
- 32771
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191713
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2019-10-18 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2019-10-18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2013-06-20 |
| Solid State Fluoroscopic X-Ray Imager | QHY | Class 2 | Radiology | No | 2025-09-05 |
Proprietary Names
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)
ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system
Soteria Eview
CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly)
Soteria.AI
Nyquist.IQ
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device