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510(k) K242418

P-Cure Proton Therapy System (PPTS) by P-Cure, Ltd. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2025
Date Received
August 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by P-Cure, Ltd.

  • K221996 — P-Cure Proton Beam Therapy System (March 20, 2023)
  • K160611 — P-ARTIS (August 8, 2016)
  • K092424 — P-ART, MODEL 001 (March 5, 2010)

Other clearances for product code LHN

  • K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (September 12, 2025)
  • K243900 — eMotus Respiratory Motion Management System (June 27, 2025)
  • K232032 — PROBEAT-FR (January 12, 2024)
  • K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) (October 6, 2023)
  • K221996 — P-Cure Proton Beam Therapy System (March 20, 2023)
  • K220883 — Small Field Applicator (December 15, 2022)
  • K221791 — ProBeam 360° Proton Therapy System (December 1, 2022)
  • K201798 — myQA iON (July 17, 2020)
  • K201042 — PROBEAT-CR (July 13, 2020)
  • K200282 — Orfit Aerial Couchtop (April 8, 2020)