BSI issues Vision RT with class IIb CE mark for the AlignRT product and ISO 13485 certification
AlignRT is a revolutionary real-time 3D surface imaging system designed for accurate patient setup and monitoring in radiotherapy.
A new version of AlignRT has been released which incorporates a range of enhancements.
In addition, the following two new modules have been developed:.
Dicom RT Import: this allows sets of contours extracted from CT via third party planning systems and exported in Dicom RT (radiotherapy industry standard) format to be imported to AlignRT.
New surfaces as acquired prior to each treatment session may thus be compared directly to the CT contour data.
PlanRT: this module allows the user to extract an unlimited number of contours from the AlignRT generated 3D surface.
In addition, a lung model is provided which together with imaged X-ray is able to estimate lung contours corresponding to each skin contour extracted from the 3D skin surface.
These data, together with user selected labelled points of interest, field borders and geometric planning information may be exported in Dicom RT or Ascii format.
The company has now received certification for ISO 13485, the international standard quality system for medical device manufacturers, following an independent audit by the British Standards Institution (BSI).
In addition, the BSI has issued a class IIb CE certificate for AlignRT and its associated modules.
This allows Vision RT to market the device as an independent contouring and positioning tool.
"We are delighted to have been awarded these class IIb and ISO 13485 certifications", says Norman Smith, CEO of Vision RT.
"We have always given the highest priority to the quality and safety of our products and it is gratifying to have had independent confirmation that our products can be used with confidence to enhance treatments and thereby help to improve cancer outcomes."
