# K130426: Sumitomo Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Sumitomo Heavy Industries, Ltd.
- Decided: Nov 19, 2013 after 272 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: 3 generations back to K872369 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053280: Probeat, Hitachi, Ltd., Power Systems Group (2006) Summary page 1.
- K983332: Northeast Proton Therapy Center, Massachusetts General Hospital (2001) Summary page 1.

## Most influential descendants
- K160612: Sumitomo Proton Therapy System (2016), 0 descendants of its own

## Indications for use
The Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K130426
Methodology: https://510kreport.com/methodology