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510(k) K132847

I2C by Ion Beam Applications S.A. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2013
Date Received
September 11, 2013
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

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  • 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)

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