510(k) K091629 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
PROTEUS 235 PROTON THERAPY SYSTEM
| Applicant | Ion Beam Applications S.A., Louvain-La-Neuve, Be-Nota, BE |
| Decision | Substantially Equivalent, Aug 11, 2009 |
| Received | Jun 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091629
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2018 | Ion Beam Applications S.A. Proteus 235
Product Usage:
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of p Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.