Xio Rtp System

• • Terminated Z-0130-2016 FDA Class II ·initiated 31 Aug 2015

  Incorrect Treatment Delivery Using Third Party Fixed Wedges.

• • Terminated Z-1197-2014 FDA Class II ·initiated 17 Feb 2014

  Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.

• • Terminated Z-0780-2014 FDA Class II ·initiated 25 Nov 2013

  When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.

• • Terminated Z-0928-2014 FDA Class II ·initiated 25 Nov 2013

  When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

• • Terminated Z-1644-2012 FDA Not yet classified ·initiated 30 Apr 2012

  XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator.

• • Terminated Z-2919-2011 FDA Unclassified (pre-2012) ·initiated 9 Jun 2011

  The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass Density should be used for Proton calculations (depending on the algorithm).

• • Terminated Z-2582-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010

  XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati

510(k) Number

K102216 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Focus

  Class II

  FDA 510(k) K002147 Active Cleared 13 Oct 2000

• Monaco Rtp System

  Class II

  FDA 510(k) K110730 Active Cleared 24 Jun 2011

• Enhanced Compensating Filter

  Class II

  FDA 510(k) K000137 Active Cleared 17 Apr 2000

• Focus Rtp System

  Class II

  FDA 510(k) K973936 Active Cleared 1 Jun 1998

• I-Beam

  Class II

  FDA 510(k) K032100 Active Cleared 2 Oct 2003

• Record and Verify Mevatron Adapter

  Class II

  FDA 510(k) K913674 Active Cleared 22 Nov 1991

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