FDA-Device2021-09-15Class II
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ion Beam Applications S.A.
Hazard
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Sold states
Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.
Affected count
27 worldwide, 11 in U.S.
Manufactured in
Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, Belgium
Products
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2434-2021Don't want to check this manually?
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