510(k) K083058 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, Apr 15, 2009 |
| Received | Oct 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083058
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.