The following data is part of a premarket notification filed by Ion Beam Application S.a. with the FDA for Proton Therapy System - Proteus 235 (proteus One, Proteus Plus, Proteus Tk2).
| Device ID | K152224 |
| 510k Number | K152224 |
| Device Name: | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | ION BEAM APPLICATION S.A. CHEMIN DU CYCLTRON 3 Louvain-la-neuve, BE 1348 |
| Contact | Anne-sophie Grell |
| Correspondent | Bruce D. Armon SAUL EWING LLP CENTER SQUARE WEST, 1500 MARKET STREET, 38TH FLOOR Philadelphia, PA 19102 -2186 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-08-09 |
| Summary: | summary |