510(k) K082416 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, Dec 12, 2008 |
| Received | Aug 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082416
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2017 | Ion Beam Applications S.A. Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton Terminated |
LHN | None listed |
| Oct 29, 2014 | Ion Beam Applications S.A. Proteus 235
Proton Therapy System for cancer treatment. Terminated |
IYE | None listed |
| Apr 24, 2014 | Ion Beam Applications S.A. Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
Proton therapy Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.