510(k) K152224 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
| Applicant | Ion Beam Application S.A., Louvain-La-Neuve, BE |
| Decision | Substantially Equivalent, Aug 9, 2016 |
| Received | Aug 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2017 | Ion Beam Applications S.A. Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a pr Terminated |
LHN | None listed |
| Jun 19, 2017 | Ion Beam Applications S.A. Proteus 235 Terminated |
LHN | None listed |
| May 3, 2017 | Ion Beam Applications S.A. Proton therapy system -Proteus 235 aka Proteus Plus.
A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptibl Terminated |
LHN | None listed |
| Mar 21, 2017 | Ion Beam Applications S.A. Proteus 235, Proton Therapy System Terminated |
LHN | None listed |
| Dec 13, 2016 | Ion Beam Applications S.A. Proteus 235, Proton Therapy System
Product Usage:
The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with local Terminated |
LHN | None listed |
| Sep 16, 2016 | Ion Beam Applications S.A. Proteus ONE and Proteus Plus Terminated |
LHN | None listed |
| Apr 11, 2016 | Ion Beam Applications S.A. The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Proteus 235, Beam Management System (PBS) Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.