FDA Registration
Active
🇺🇸 United States
QPIX SOLUTIONS, INC.
Reg #: 3025442726
·
FEI: 3025442726
·
Expires 2026
Products
8
Proprietary Names
31
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- QPIX SOLUTIONS, INC.
- Registration Number
- 3025442726
- FEI Number
- 3025442726
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2933 S Miami Blvd Ste 119, Durham, NC 27703-9041
- City
- Durham
- State
- NC
- ZIP
- 27703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171420
Owner / Operator
- Firm Name
- QPIX SOLUTIONS, INC.
- Operator Number
- 10086838
- Address
- 1001 Aviation Parkway Suite 200
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Richard Jeon
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 | 2023-05-22 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2023-05-26 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-05-23 |
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2025-05-23 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2026-03-24 |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2025-04-21 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-10-08 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2025-12-23 |
Proprietary Names
1717SCC
1212FCA
1717scv, 1717sgv
X-CELL X-RAY
1717wcc, 1717wgc
1417WCE
1417WCE-GF
1417WCE-HS
1417WCE-HR
Edge Air
1012wcc, 1012wgc
Edge Air(1417)
1717WCE-GF
1717WCE-HS
1717WCE-HR
1717WCE
2430TCA
Airbile-100
Mobile x-ray system
1417WCC
Edge
CMP200 Generator
1717FCC
Smart Stitching
0909FCC-HS
0909FCC
EzSensor HD (IOS-U20IF)
EzSensor HD (IOS-U10IF)
EzSensor HD (IOS-U15IF)
0909fcb, 1212fca
1417WGC
Establishment Types
Repack or Relabel Medical Device