FDA Registration
Active
🇺🇸 United States
RADIOLOGY INFORMATION SYSTEMS, INC.
Reg #: 1125622
·
FEI: 3002952981
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- RADIOLOGY INFORMATION SYSTEMS, INC.
- Registration Number
- 1125622
- FEI Number
- 3002952981
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43676 TRADE CENTER PLACE, SUITE 100
- City
- DULLES
- State
- VA
- ZIP
- 20166
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102849
Owner / Operator
- Firm Name
- RADIOLOGY INFORMATION SYSTEMS, INC.
- Operator Number
- 9029503
- Address
- 43676 TRADE CENTER PLACE, SUITE 100
- City
- Dulles
- State
- VA
- Postal Code
- 20166
- Country
- US
- Correspondent
- Chen-Tai - MA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2022-11-21 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2010-11-29 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2022-01-28 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2022-01-28 |
Proprietary Names
RSVS
AccuImaging
PowerDR PACS
Establishment Types
Manufacture Medical Device