510(k) K061913 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
IBA PROTON THERAPY SYSTEM - PROTEUS 235
| Applicant | Ion Beam Applications S.A., Philadelphia PA, US |
| Decision | Substantially Equivalent, Jul 28, 2006 |
| Received | Jul 6, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2021 | Ion Beam Applications S.A. Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Open, Classified |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.