# K134052: Radiance 330 Proton Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Protom International, Inc.
- Decided: Mar 14, 2014 after 73 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: 5 generations back to K872369 (1988). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082416: Iba Proton Therapy System- Proteus 235, Ion Beam Applications S.A. (2008) Summary page 3.
- K073059: Probeat with Discrete Spot Scanning System, Hitachi, Ltd., Power Systems Group (2007) Summary page 3.
- K992414: Proton Beam Therapy System (PBTS), Optivus Technology, Inc. (2000) Summary page 3.

## Most influential descendants
- K191521: Radiance 330 Proton Beam Therapy System (2019), 2 descendants of its own
- 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
- K160063: McLaren Proton Therapy System (2016), 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 conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K134052
Methodology: https://510kreport.com/methodology