The following data is part of a premarket notification filed by Ion Beam Applications S.a. with the FDA for Modification To Iba Proton Therapy System-proteus 235.
| Device ID | K101508 |
| 510k Number | K101508 |
| Device Name: | MODIFICATION TO 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 B Reiss |
| Correspondent | John B 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-08-06 |
| Summary: | summary |