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510(k) K163500

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) by Ion Beam Applications S.A. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
December 13, 2016
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 Ion Beam Applications S.A.

  • K132919 — GANTRY BEAM LINE (July 10, 2014)
  • K132847 — I2C (November 20, 2013)
  • K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 (August 6, 2010)
  • K100766 — IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 (July 21, 2010)
  • K092796 — IBA PROTON THERAPY SYSTEM, PROTEUS 235 (December 22, 2009)
  • K091629 — PROTEUS 235 PROTON THERAPY SYSTEM (August 11, 2009)
  • K083058 — IBA PROTON THERAPY SYSTEM - PROTEUS 235 (April 15, 2009)
  • K082416 — IBA PROTON THERAPY SYSTEM- PROTEUS 235 (December 12, 2008)
  • K061913 — IBA PROTON THERAPY SYSTEM - PROTEUS 235 (July 28, 2006)
  • K060695 — IBA PROTON THERAPY SYSTEM - PROTEUS 235 (April 11, 2006)

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)
  • 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)