VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER

Primary DI

03760290230040

Basic UDI-DI Code

376029023SDX0306M9474LJW3

Reference

SDX0306V3.0_M9474-D

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

The SDX System is intended for use in Radiation Therapy as an aid in allowing the patient and treatment staff to visualize a patient breathing process and to optimize breathing to limit internal motion during imaging & treatment. The target population are patients who suffer from cancers in the thoraco-abdominal region and require radiation imaging and treatment, and capable of understanding and following the radiotherapist’s instructions.

The SDX System is intended for use in Radiation Therapy as an aid in allowing the patient and treatment staff to visualize a patient breathing process and to optimize breathing to limit internal motion during imaging & treatment. The SDX System with the Gating Module interface is used to provide respiratory synchronization for both radiation therapy imaging equipment and for radiation treatment equipment (photon & proton particle systems). Indication : Population with thoracoabdominal cancer undergoing radiotherapy and capable of understanding and following the instructions of radiotherapists.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).