# K060695: Iba Proton Therapy System - Proteus 235

- Pathway: 510(k) (Special)
- Applicant: Ion Beam Applications S.A.
- Decided: Apr 11, 2006 after 26 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K872369 (1988). 3 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 28 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 1.
- K053641: Iba Proton Therapy System-Proteus 235, Ion Beam Applications S.A. (2006) Summary page 1.

## Most influential descendants
- K073059: Probeat with Discrete Spot Scanning System (2007), 16 descendants of its own
- K151132: Probeat-V (2015), 10 descendants of its own
- K152592: Probeat-V (2015), 7 descendants of its own
- K062891: Proton Therapy System (2006), 6 descendants of its own
- K120676: S-250 Proton Beam Radiation Therapy System (2012), 5 descendants of its own

## Recalls of this device
- Jun 27, 2018 · Class II · Z-2470-2018: Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or us
- Dec 5, 2017 · Class II · Z-0934-2018: An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.

## Indications for use
The 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.

Source page: https://510kreport.com/device/K060695
Methodology: https://510kreport.com/methodology