# K061913: Iba Proton Therapy System - Proteus 235

- Pathway: 510(k) (Special)
- Applicant: Ion Beam Applications S.A.
- Decided: Jul 28, 2006 after 22 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872369 (1988). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872369: Loma Linda Univ. Proton Beam Therapy System, Loma Linda University Medical Center (1988) Summary page 1.
- (no number) Harvard University Cyclotron Laboratory Proton Beam Therapy device: named in the summary without a submission number

## Most influential descendants
- K120676: S-250 Proton Beam Radiation Therapy System (2012), 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
- Jun 14, 2021 · Class II · Z-2434-2021: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

## 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/K061913
Methodology: https://510kreport.com/methodology