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FDA 510(k)

P-Cure Proton Therapy System (PPTS)

K-Number: K242418 · 2025-05-12

ApplicantP-Cure, Ltd.
Decision Date2025-05-12
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P-Cure Proton Therapy System (PPTS) is a medical device manufactured by P-Cure, Ltd.. It received FDA 510(k) clearance on 2025-05-12 under approval number K242418. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P-Cure Proton Therapy System (PPTS)?

P-Cure Proton Therapy System (PPTS) is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by P-Cure, Ltd.. The 510(k) number is K242418.

When was P-Cure Proton Therapy System (PPTS) approved by the FDA?

P-Cure Proton Therapy System (PPTS) received FDA 510(k) clearance on 2025-05-12, under approval number K242418.

What company makes P-Cure Proton Therapy System (PPTS)?

P-Cure Proton Therapy System (PPTS) is manufactured by P-Cure, Ltd..

What is the FDA product code for P-Cure Proton Therapy System (PPTS)?

The FDA product code for P-Cure Proton Therapy System (PPTS) is LHN.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by P-Cure, Ltd.

K160611P-ARTIS K221996P-Cure Proton Beam Therapy System

Related Devices (Code: LHN)

K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd. K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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