FDA Registration
Active
🇧🇪 Belgium
Proteus Plus
Reg #: 3000256071
·
FEI: 3000256071
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ION BEAM APPLICATIONS S.A.
- Registration Number
- 3000256071
- FEI Number
- 3000256071
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3 CHEMIN DU CYCLOTRON
- City
- LOUVAIN-LA-NEUVE, BE Brabant Wallon
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K163500
Owner / Operator
- Firm Name
- ION BEAM APPLICATIONS S.A.
- Operator Number
- 9034929
- Address
- 3 CHEMIN DU CYCLOTRON, --
- City
- LOUVAIN-LA-NEUVE, BE
- State
- BE-NOTA
- Postal Code
- 1348
- Country
- BE
- Correspondent
- Ronald - Wichern
US Agent
- Business Name
- IBA Proton Therapy Inc.
- Contact Name
- Todd Bejian
- Address
- 470 Spring Park Place, Suite 700
- City
- Herndon
- State
- VA
- ZIP
- 20170
- Country
- US
- [email protected]
- Phone
- 703 2346561
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2017-12-14 |
Proprietary Names
Proteus Plus
Proteus One
Proton Therapy System - Proteus 235
Establishment Types
Manufacture Medical Device