The following data is part of a premarket notification filed by Ion Beam Applications S.a. with the FDA for Iba Proton Therapy System- Proteus 235.
| Device ID | K082416 |
| 510k Number | K082416 |
| Device Name: | IBA PROTON THERAPY SYSTEM- PROTEUS 235 |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | ION BEAM APPLICATIONS S.A. 1500 MARKET STREET CENTRE SQUARE WEST, 38TH FLOOR Philadelphia, PA 19102 |
| Contact | John Reiss |
| Correspondent | John Reiss ION BEAM APPLICATIONS S.A. 1500 MARKET STREET CENTRE SQUARE WEST, 38TH FLOOR Philadelphia, PA 19102 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-21 |
| Decision Date | 2008-12-12 |
| Summary: | summary |