Xio Rtp System

• • Terminated Z-2579-2011 FDA Unclassified (pre-2012) ·initiated 3 Oct 2010

  XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port

• • Terminated Z-2408-2011 FDA Unclassified (pre-2012) ·initiated 10 Sep 2010

  When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate.

• • Terminated Z-2595-2011 FDA Unclassified (pre-2012) ·initiated 28 May 2010

  XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had always been done manually by the user. This is functionality that has never been provided on XiO. The problem occurs because XiO is not storing a persistent DICOM

• • Terminated Z-2593-2011 FDA Unclassified (pre-2012) ·initiated 27 May 2010

  XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated.

• • Terminated Z-2407-2011 FDA Unclassified (pre-2012) ·initiated 27 May 2010

  XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO.

• • Terminated Z-2604-2011 FDA Unclassified (pre-2012) ·initiated 19 May 2010

  XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.

• • Terminated Z-1655-2010 FDA Unclassified (pre-2012) ·initiated 15 Apr 2010

  Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening

• • Terminated Z-1209-2010 FDA Unclassified (pre-2012) ·initiated 22 Feb 2010

  Inconsistent MLC positions, dose, and monitor units

• • Terminated Z-2568-2011 FDA Unclassified (pre-2012) ·initiated 13 May 2009

  In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.

• • Terminated Z-2567-2011 FDA Unclassified (pre-2012) ·initiated 9 Dec 2008

  XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re

• • Terminated Z-2574-2011 FDA Unclassified (pre-2012) ·initiated 14 May 2008

  In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.

• • Terminated Z-2577-2011 FDA Unclassified (pre-2012) ·initiated 8 Apr 2008

  XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.

510(k) Number

K092132 ↗

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

See all devices from Computerized Medical Systems, Inc. →