# K152224: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Application S.A.
- Decided: Aug 9, 2016 after 368 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K872369 (1988). 14 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132919: Gantry Beam Line, Ion Beam Applications S.A. (2014) Summary page 5.
- K120676: S-250 Proton Beam Radiation Therapy System, Mevion Medical Systems (2012) Summary page 5.

## Most influential descendants
- K172848: MEVION S250i Proton Beam Radiation Therapy Device (2017), 2 descendants of its own
- K250986: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (2025), 1 descendant of its own
- K253406: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (2026), 0 descendants of its own
- K163500: IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) (2017), 0 descendants of its own

## Recalls of this device
- Nov 1, 2017 · Class II · Z-0943-2018: The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
- Apr 10, 2017 · Class II · Z-2097-2017: A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered do
- Mar 21, 2017 · Class II · Z-1830-2017: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
- Feb 9, 2017 · Class II · Z-2592-2017: It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mod
- Dec 13, 2016 · Class II · Z-2684-2017: Software issue
- Sep 16, 2016 · Class II · Z-2139-2018: IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
- Apr 11, 2016 · Class II · Z-2284-2018: IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

## Indications for use
“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.”

Source page: https://510kreport.com/device/K152224
Methodology: https://510kreport.com/methodology