Focal Sim

• • Terminated Z-1244-2015 FDA Class II ·initiated 19 Dec 2014

  Incorrect CT to ED when using the Monaco Image Statistics Tool.

• • Terminated Z-2574-2014 FDA Class II ·initiated 18 Aug 2014

  When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

• • Terminated Z-2002-2012 FDA Class II ·initiated 21 Jun 2012

  Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

• • Terminated Z-2562-2011 FDA Unclassified (pre-2012) ·initiated 9 Nov 2010

  Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment.

• • Terminated Z-2592-2011 FDA Unclassified (pre-2012) ·initiated 10 May 2010

  Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.

• • Terminated Z-2559-2011 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.

• • Terminated Z-2599-2011 FDA Unclassified (pre-2012) ·initiated 6 Feb 2009

  Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to

• • Terminated Z-2594-2011 FDA Unclassified (pre-2012) ·initiated 19 Jan 2009

  Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.

• • Terminated Z-2572-2011 FDA Unclassified (pre-2012) ·initiated 31 Mar 2008

  Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as

• • Terminated Z-2596-2011 FDA Unclassified (pre-2012) ·initiated 30 Nov 2007

  Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (col

510(k) Number

K013112 ↗

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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