Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)— 510(k) K152224
Substantially EquivalentIon Beam Application S.A.
FDA 510(k) clearance K152224 for Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2), Substantially Equivalent on 2016-08-09. Applicant: Ion Beam Application S.A.. Device class: 2.
Clearance details
- Applicant
- Ion Beam Application S.A.
- Product code
- Code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louvain-La-Neuve, BE
Recent devices under product code LHN
view allRecalls naming K152224
K-number listed on FDA's recall record- Z-0943-2018 — 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 proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Z-2097-2017 — 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 susceptible to treatment by radiation.
- Z-1830-2017 — Proteus 235, Proton Therapy System
- Z-2592-2017 — Proteus 235
- Z-2684-2017 — 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 localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Z-2139-2018 — Proteus ONE and Proteus Plus
- Z-2284-2018 — The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152224.
Data sourced from openFDA. This site is unofficial and independent of the FDA.