RayCare (2024A SP1)
RaySearch Laboratories AB (publ)RayCare (2024A SP1) is a software system designed to support cancer treatment by assisting clinicians with treatment planning, management, scheduling, and follow-up for radiation therapy and oncology care. It includes an image viewer for reviewing and annotating images related to patient positioning during treatment, aiding clinicians in delivering precise radiotherapy treatment.
Intended Use
RayCare is an oncology information system intended to provide information used for diagnosis, treatment management, planning, scheduling, and follow-up of radiation therapy, medical oncology, and surgical oncology. It enables definition of clinical treatment intent, prescribing treatment, treatment delivery management, and monitoring. The image viewer can be used for viewing, annotating images, performing and saving image registrations and fusion to enable offline review of patient positioning during radiation therapy. It is not intended for diagnostic use.
Technology
RayCare is a software-as-a-medical device with client and server components. It supports workflow management for cancer treatments, image viewing, image annotation, image registration, and fusion. It integrates with treatment devices such as Varian TrueBeam, supports scripting for data handling, task and workflow management, and external system integrations. The system enables offline and online recording of treatment results, including importing DICOM treatment records.
Performance
Software verification and validation was performed including unit, integration, system, usability, regression, and cybersecurity testing. Validation showed the device is as safe and effective as the predicate device with no new safety or effectiveness questions. No animal or clinical testing were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/26/2024
6 months - 2
FDA Approval
4/17/2025
Other devices from RaySearch Laboratories AB (publ)
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.