| Primary Device ID | 05404013801138 |
| NIH Device Record Key | 5f7f7467-12f8-49fc-b6ed-2c16efcee981 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IBA Proton Therapy System – Proteus 235 |
| Version Model Number | Proteus PLUS/Proteus ONE |
| Company DUNS | 372078154 |
| Company Name | Ion Beam Applications SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05404013801138 [Primary] |
| LHN | System, Radiation Therapy, Charged-Particle, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2021-02-28 |
| 05404013801138 - IBA Proton Therapy System – Proteus 235 | 2021-03-08Proton Therapy System |
| 05404013801138 - IBA Proton Therapy System – Proteus 235 | 2021-03-08 Proton Therapy System |
| 05404013802012 - I2C (IBA Image-Guided Therapy Console) | 2020-08-17 Image-Guided Therapy Console |
| 05404013834013 - I2C (IBA Image-Guided Therapy Console) | 2020-02-11 Image-Guided Therapy Console |
| 05404013831258 - I2C (IBA Image-Guided Therapy Console) | 2019-10-04 Image-Guided Therapy Console |
| 05404013831906 - I2C (IBA Image Guided Therapy Console) | 2019-10-04 Image Guided Therapy Console |
| 05404013814015 - Proteus 235 | 2018-09-03 IBA Proton Therapy System – Proteus 235 |
| 05404013810901 - Proteus 235 | 2018-03-29 IBA Proton Therapy System – Proteus 235 |
| 05404013813308 - Proteus 235 | 2018-03-29 IBA Proton Therapy System – Proteus 235 |