The following data is part of a premarket notification filed by Ion Beam Applications S.a. with the FDA for Proteus 235 Proton Therapy System.
| Device ID | K091629 |
| 510k Number | K091629 |
| Device Name: | PROTEUS 235 PROTON THERAPY SYSTEM |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | ION BEAM APPLICATIONS S.A. 3 CHEMIN DU CYCLOTRON Louvain-la-neuve, Be, BE 1348 |
| Contact | Yves Jongen |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-08-11 |