# K160063: McLaren Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Mclaren Health Care Corporation
- Decided: Feb 25, 2016 after 43 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: 6 generations back to K872369 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134052: Radiance 330 Proton Therapy System, Protom International, Inc. (2014) Summary page 4.

## Indications for use
The McLaren Proton Therapy System 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/K160063
Methodology: https://510kreport.com/methodology