# K160612: Sumitomo Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Sumitomo Heavy Industries, Ltd.
- Decided: Aug 17, 2016 after 167 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130426: Sumitomo Proton Therapy System, Sumitomo Heavy Industries, Ltd. (2013) Summary page 4.

## 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/K160612
Methodology: https://510kreport.com/methodology