VARIAN MEDICAL SYSTEMS INC
ECLIPSE · General and Plastic Surgery
510(k) Clearances (19)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Recalls (10)
There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation ima…
Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open.
An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse.
An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.
The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.