FDA 510(k), K083058, IBA PROTON THERAPY SYSTEM - PROTEUS 235

FDA 510(k), K083058, IBA PROTON THERAPY SYSTEM - PROTEUS 235

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510(K) Number: K083058
Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235
Manufacturer: JOHN B REISS
Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical
Regulation Number: LHN
Classification Product Code: KXA
Date Received: 10/14/2008
Decision Date: 04/15/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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