FDA-Device2019-01-16Class II
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 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.
Ion Beam Applications S.A.
Hazard
There is a risk of detachment of the Compact Gantry Rolling Floor.
Sold states
Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.
Affected count
7
Manufactured in
Chemin Du Cyclotron 3, Louvain-la-neuve, Belgium
Products
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 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-0698-2019Don't want to check this manually?
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