# K100766: Iba Proton Therapy System, Model Proteus 235

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Applications S.A.
- Decided: Jul 21, 2010 after 126 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 3 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.

## 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. The PTS may include a Fixed Small beam Treatment Room dedicated to treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localised to the head and neck.

Source page: https://510kreport.com/device/K100766
Methodology: https://510kreport.com/methodology