# K062891: Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Indiana University Cyclotron Facility
- Decided: Dec 14, 2006 after 79 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: 4 generations back to K872369 (1988). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 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.
- K983024: Proton Therapy System, Ion Beam Applications S.A. (2001) Summary page 1.
- K060695: Iba Proton Therapy System - Proteus 235, Ion Beam Applications S.A. (2006) Summary page 1.

## 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

## Indications for use
Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

Source page: https://510kreport.com/device/K062891
Methodology: https://510kreport.com/methodology