The DirectBrachy positioning board is currently under development; it is not for sale in the U.S.A.
The DirectBrachy positioning board is not commercially available in all countries. Its future availability cannot be guaranteed.
The urology stirrups (leg support) seen here are optional. The information contained here refers to products from third party manufacturers and are therefore in their regulatory responsibility.
The CT simulator and the CT table seen here are not part of the DirectBrachy positioning board.
DirectBrachy positioning board is only compatible with SOMATOM go.Sim and SOMATOM go.Open Pro with Multi-index RTP Overlay. Afterloader needed for brachytherapy. Shielding of the CT room is required when it its used for brachytherapy.
Verification of mutual compatibility of medical devices combined in a system in accordance with Article 22 (MDR Regulation (EU) 2017/745) on Medical Devices is pending. The combination is not commercially available in the European Union.
The DirectBrachy positioning board does not yet fulfill all applicable General Safety and Performance Requirements according to the European Medical Device Regulation 2017/745. The product is not commercially available. Its future availability cannot be guaranteed.