RayCare (2024A SP1)

RayCare 2024A SP1 is an oncology information system that manages clinical and administrative workflows for radiation therapy, medical oncology, and surgical oncology. It enables users to define treatment intent, prescribe treatment, plan delivery, manage treatment courses, and monitor progress. The system includes an image viewer for viewing, annotating, registering, and fusing images for offline review of patient positioning during treatment delivery.

RayCare 2024A SP1 adds multiple software enhancements to the predicate RayCare 3B, including expanded patient chart features (family history, implantable device lists, social history documentation), PACS archiving support, Python scripting capabilities, improved workflow management with parallel workflow support, updated whiteboard displays, treatment course management functionality, extended diagnosis coding (ICD-0-3), toxicity management, and integration frameworks for treatment devices like Varian TrueBeam.

Compliance demonstrated with IEC 61217 (radiotherapy equipment coordinates), IEC 62304 (medical device software lifecycle), IEC 62366-1 (usability engineering), and ISO 14971 (risk management). Testing included unit testing, integration testing, system-level testing, cybersecurity testing, usability testing, and regression testing of software verification and validation activities.

The subject device maintains the same principle of operation and intended use as the predicate device—both are oncology information systems for managing radiation therapy workflows. Although RayCare 2024A SP1 includes numerous software feature enhancements, these are characterized as incremental improvements rather than fundamental changes to safety or effectiveness. Comprehensive software verification and validation demonstrated that the new features do not raise different questions of safety or effectiveness, and the device performs as well as the predicate. Compliance with recognized consensus standards and successful validation of key features (treatment course management, scripting, treatment recording, and TrueBeam integration) support the determination of substantial equivalence.