FDA-Device2024-09-18Class II
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Ion Beam Applications S.A.
Hazard
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Sold states
Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.
Affected count
35 units
Manufactured in
Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, Belgium
Products
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3089-2024Don't want to check this manually?
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