P-Cure Proton Therapy System (PPTS)— 510(k) K242418

Name: FDA 510(k) clearance K242418
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Substantially Equivalent

P-Cure, Ltd.

FDA 510(k) clearance K242418 for P-Cure Proton Therapy System (PPTS), Substantially Equivalent on 2025-05-12. Applicant: P-Cure, Ltd.. Device class: 2.

Clearance details

Applicant: P-Cure, Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2024-08-15
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shilat Industrial Zone, IL

Download summary PDF View on FDA.gov ↗

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More clearances from P-Cure, Ltd.

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K221996 — P-Cure Proton Beam Therapy System2023-03-20
K160611 — P-ARTIS2016-08-08
K092424 — P-ART, MODEL 0012010-03-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.