FDA-Device2014-11-05Class II
Proteus 235 Proton Therapy System for cancer treatment.
Ion Beam Applications S.A.
Hazard
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Sold states
Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
Affected count
8
Manufactured in
Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, Belgium
Products
Proteus 235 Proton Therapy System for cancer treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0020-2015Don't want to check this manually?
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