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 (proteus One, Proteus Plus, Proteus Tk2, Proteus Class).
| Device ID | K163500 |
| 510k Number | K163500 |
| Device Name: | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Ion Beam Applications S.A. Chemin Du Cyclotron, 3 Louvain-la-neuve, BE 1348 |
| Contact | Anne-sophie Grell |
| Correspondent | Bruce D Armon SAUL EWING LLP 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 | 2016-12-13 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05404013801138 | K163500 | 000 |