# K132919: Gantry Beam Line

- Pathway: 510(k) (Traditional)
- Applicant: Ion Beam Applications S.A.
- Decided: Jul 10, 2014 after 296 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.
5 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)
- K101508: Modification to Iba Proton Therapy System-Proteus 235, Ion Beam Applications S.A. (2010)

## Most influential descendants
- 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
- 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
- Aug 7, 2016 · Class II · Z-2173-2018: IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
- May 18, 2016 · Class II · Z-2672-2017: Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

## 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. 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/K132919
Methodology: https://510kreport.com/methodology