Ion Beam Applications S.A.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Ion Beam Applications S.A.” (first 2001, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 102 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 70 |
| 2014 | 1 | 296 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 247 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ion Beam Applications S.A. took a median 247 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 13 | 13 |
Review panels
- Radiology (13)
Most recent Ion Beam Applications S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | LHN | 2017-08-17 | 247 |
| K132919 | GANTRY BEAM LINE | LHN | 2014-07-10 | 296 |
| K132847 | I2C | LHN | 2013-11-20 | 70 |
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | LHN | 2010-08-06 | 66 |
| K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | LHN | 2010-07-21 | 126 |
| K092796 | IBA PROTON THERAPY SYSTEM, PROTEUS 235 | LHN | 2009-12-22 | 102 |
| K091629 | PROTEUS 235 PROTON THERAPY SYSTEM | LHN | 2009-08-11 | 69 |
| K083058 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | LHN | 2009-04-15 | 183 |
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | LHN | 2008-12-12 | 113 |
| K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | LHN | 2006-07-28 | 22 |
3 earlier clearances. See the full list in Caduvo.
Recalls
36 product recalls in 35 recall events; 9 initiated in the last five years. Most recent: 2026-02-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ion Beam Applications S.A.?
FDA lists 13 510(k) clearances under the applicant name “Ion Beam Applications S.A.” (first 2001, latest 2017), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ion Beam Applications S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ion Beam Applications S.A. is 102 days.
Which FDA product codes appear under Ion Beam Applications S.A.?
The most frequent FDA product codes under this applicant name are LHN (System, Radiation Therapy, Charged-Particle, Medical, 13).
Next steps
- See all 13 Ion Beam Applications S.A. clearances with predicates and recalls
- Run predicate analysis for product code LHN, Ion Beam Applications S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.