FDA Registration
Active
🇸🇪 Sweden
Encompass SRS Headframe ; Encompass MR SRS Headframe
Reg #: 3015232217
·
FEI: 3015232217
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ELEKTA SOLUTIONS AB
- Registration Number
- 3015232217
- FEI Number
- 3015232217
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hagaplan 4
- City
- STOCKHOLM
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K182189
Owner / Operator
- Firm Name
- ELEKTA AB
- Operator Number
- 8030893
- Address
- Hagaplan 4
- City
- Stockholm
- State
- SE-AB
- Postal Code
- SE11368
- Country
- SE
US Agent
- Business Name
- Elekta Inc.
- Contact Name
- Thomas Valentine
- Address
- 400 Perimeter Center Terrace, Suite 50
- City
- ATL
- State
- GA
- ZIP
- 30346
- Country
- US
- [email protected]
- Phone
- 404 7972537
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-05-16 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2025-05-16 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2025-05-16 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2025-05-16 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2025-05-16 |
| Couch, Radiation Therapy, Powered | JAI | Class 2 | Radiology | No | 2025-05-16 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2025-05-16 |
Proprietary Names
Encompass SRS Headframe ; Encompass MR SRS Headframe
Establishment Types
Export Device to the United States But Perform No Other Operation on Device