Cleared Traditional

P-Cure Proton Therapy System (PPTS)

K242418 · P-Cure, Ltd. · Radiology
May 2025
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K242418 is an FDA 510(k) clearance for the P-Cure Proton Therapy System (PPTS), a System, Radiation Therapy, Charged-particle, Medical (Class II — Special Controls, product code LHN), submitted by P-Cure, Ltd. (Shilat Industrial Zone, IL). The FDA issued a Cleared decision on May 12, 2025, 270 days after receiving the submission on August 15, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K242418 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2024
Decision Date May 12, 2025
Days to Decision 270 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LHN — System, Radiation Therapy, Charged-particle, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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