Device Recall Radiation Therapy Treatment Planning System

Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.

Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.