Sites affected will be those meeting ALL three criteria below:
1- Running Monaco Release 3.30 and higher
2- Using a CT Slice Spacing not equal to the CT Slice Thickness
3- Using the Image Statistics Tool to quantify CT phantom densities which are then used to populate the CT to ED file.
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FDA update code :
Focal Sim, Focal Release 4.80
Product Description
Radiotherapy, planning and verification systems software