# K163500: IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Applications S.A.
- Decided: Aug 17, 2017 after 247 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K872369 (1988). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152224: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2), Ion Beam Application S.A. (2016) Summary page 5.

## Recalls of this device
- Feb 3, 2026 · Class II · Z-1497-2026: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if th
- Jul 10, 2024 · Class II · Z-2693-2024: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
- Jul 8, 2024 · Class II · Z-3089-2024: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
- May 10, 2024 · Class II · Z-1945-2024: Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
- Mar 4, 2024 · Class II · Z-1603-2024: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
- Sep 18, 2023 · Class II · Z-0295-2024: The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
- Apr 20, 2022 · Class II · Z-1205-2022: First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may r
- Feb 15, 2022 · Class II · Z-0747-2022: When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an oper
- Nov 29, 2021 · Class II · Z-0466-2022: Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the
- Jul 17, 2020 · Class II · Z-2715-2020: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
- Apr 21, 2020 · Class II · Z-2773-2020: Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is 

## Indications for use
The IBA Proton Therapy System (PTS) 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/K163500
Methodology: https://510kreport.com/methodology