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FDA 510(k)

P-Cure Proton Beam Therapy System

K-Number: K221996 · 2023-03-20

ApplicantP-Cure, Ltd.
Decision Date2023-03-20
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P-Cure Proton Beam Therapy System is a medical device manufactured by P-Cure, Ltd.. It received FDA 510(k) clearance on 2023-03-20 under approval number K221996. 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 Beam Therapy System?

P-Cure Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2023-03-20. It is manufactured by P-Cure, Ltd.. The 510(k) number is K221996.

When was P-Cure Proton Beam Therapy System approved by the FDA?

P-Cure Proton Beam Therapy System received FDA 510(k) clearance on 2023-03-20, under approval number K221996.

What company makes P-Cure Proton Beam Therapy System?

P-Cure Proton Beam Therapy System is manufactured by P-Cure, Ltd..

What is the FDA product code for P-Cure Proton Beam Therapy System?

The FDA product code for P-Cure Proton Beam Therapy System is LHN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by P-Cure, Ltd.

K160611P-ARTIS K242418P-Cure Proton Therapy System (PPTS)

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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