510(k) K060695 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 11, 2006 |
| Received | Mar 16, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2018 | Ion Beam Applications S.A. Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL
Product Usage:
Device is designed to produce and deliver proton beam for the treatment of patients with localized Terminated |
LHN | None listed |
| Dec 5, 2017 | Ion Beam Applications S.A. Proteus 235, Uniform and Pencil Beam Scanning
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 Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.