# K191521: Radiance 330 Proton Beam Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Protom International Holding Corporation
- Decided: Sep 27, 2019 after 112 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.
2 later devices descend from it; 1 cites it directly.
0 of 13 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.

## Most influential descendants
- K221996: P-Cure Proton Beam Therapy System (2023), 1 descendant of its own
- K242418: P-Cure Proton Therapy System (PPTS) (2025), 0 descendants of its own

## Indications for use
The ProTom Radiance 330 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K191521
Methodology: https://510kreport.com/methodology