Device product
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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.
Z-0931-2018
Product summary
- Event
- Event 79228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0931-2018
Official wording
Reason: Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
Code information: PAT.003 (KR), PAT.006 (US)
Distribution pattern: US Distribution to the state of :FL
Derived failure modes
-
Unknown
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.