510(k) K132919 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
GANTRY BEAM LINE
| Applicant | Ion Beam Applications S.A., Philadelphia PA, US |
| Decision | Substantially Equivalent, Jul 10, 2014 |
| Received | Sep 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2016 | Ion Beam Applications S.A. Proteus 235
The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Terminated |
LHN | None listed |
| May 18, 2016 | Ion Beam Applications S.A. Proteus 235 and Proteus ONE proton therapy systems Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.