# K101508: Modification to Iba Proton Therapy System-Proteus 235

- Pathway: 510(k) (Special)
- Applicant: Ion Beam Applications S.A.
- Decided: Aug 6, 2010 after 66 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872369 (1988). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983024: Proton Therapy System, Ion Beam Applications S.A. (2001) Summary page 2.

## Most influential descendants
- K132919: Gantry Beam Line (2014), 5 descendants of its own
- K152224: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (2016), 4 descendants of its own
- 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

## Recalls of this device
- May 26, 2021 · Class II · Z-2155-2021: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribe
- May 16, 2018 · Class II · Z-2424-2018: Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position inst
- Jan 26, 2018 · Class II · Z-1477-2018: When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is reque
- Nov 17, 2017 · Class II · Z-0938-2018: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
- Oct 17, 2017 · Class II · Z-0930-2018: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
- Mar 9, 2017 · Class II · Z-1695-2017: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

## Indications for use
The Proton Therapy System — Proteus 235 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.

Source page: https://510kreport.com/device/K101508
Methodology: https://510kreport.com/methodology