# K242418: P-Cure Proton Therapy System (PPTS)

- Pathway: 510(k) (Traditional)
- Applicant: P-Cure, Ltd.
- Decided: May 12, 2025 after 270 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: 8 generations back to K872369 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221996: P-Cure Proton Beam Therapy System, P-Cure, Ltd. (2023) Summary page 5.

## Indications for use
The PPTS 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. When the patient is in the seated position using the chair, the System is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the head, neck and thorax.

Source page: https://510kreport.com/device/K242418
Methodology: https://510kreport.com/methodology