FDA-Device2018-03-14Class II

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 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 locali

Ion Beam Applications S.A.
Hazard

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

Sold states
US Distribution to the state of :FL
Affected count
3
Manufactured in
Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, Belgium
Products
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 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0931-2018

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