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510(k) K221996

P-Cure Proton Beam Therapy System by P-Cure, Ltd. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2023
Date Received
July 6, 2022
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.

  • K242418 — P-Cure Proton Therapy System (PPTS) (May 12, 2025)
  • 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)
  • K242418 — P-Cure Proton Therapy System (PPTS) (May 12, 2025)
  • K232032 — PROBEAT-FR (January 12, 2024)
  • K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) (October 6, 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)