Cleared Traditional

P-Cure Proton Beam Therapy System

K221996 · P-Cure, Ltd. · Radiology
Mar 2023
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K221996 is an FDA 510(k) clearance for the P-Cure Proton Beam Therapy System, 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 March 20, 2023, 257 days after receiving the submission on July 6, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K221996 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2022
Decision Date March 20, 2023
Days to Decision 257 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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