# K162246: ProNova SC360 Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Pronova Solutions, LLC
- Decided: Dec 8, 2016 after 120 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: 2 generations back to K872369 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083058: Iba Proton Therapy System - Proteus 235, Ion Beam Applications S.A. (2009) Summary page 5.

## Indications for use
The SC360 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/K162246
Methodology: https://510kreport.com/methodology