FDA-Device2018-07-25Class II
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 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
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
Sold states
US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.
Affected count
14
Manufactured in
Chemin Du Cyclotron 3, Louvain-la-neuve, Belgium
Products
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 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-2470-2018Don't want to check this manually?
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