FDA Registration
Active
🇺🇸 United States
RADLINK, INC.
Reg #: 3005560996
·
FEI: 3005560996
·
Expires 2026
Products
1
Proprietary Names
14
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- RADLINK, INC.
- Registration Number
- 3005560996
- FEI Number
- 3005560996
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2101 E El Segundo Blvd, Suite 104
- City
- El Segundo
- State
- CA
- ZIP
- 90245
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142718
Owner / Operator
- Firm Name
- RADLINK, INC.
- Operator Number
- 9048903
- Address
- 2101 E El Segundo Blvd, Suite 104, --
- City
- El Segundo
- State
- CA
- Postal Code
- 90245
- Country
- US
- Correspondent
- THOMAS T HACKING
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 | 2015-12-31 |
Proprietary Names
Radlink WCA Kit
Radlink Bucky Cart
Radlink GPS Tablet
Radlink Wireless C-Arm Kit
Radlink Pro Imaging Software
Radlink Surgeon's Checklist Software
Radlink PACS
Radlink DR Pro
Radlink Galileo Positioning System
Radlink GPS
Radlink digital radiography system
Radlink OR Pro
Galileo Positioning System (GPS)
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device