# Intended Use ## Mapping of Requirements to Document Sections | MDR Class | MDR Section | Document Section | | --------- | ----------------------------- | ---------------- | | (All) | Annex II, 1.1 a) - d), h), i) | (All) | | ISO 14971:2019 Section | Document Section | | ---------------------- | ---------------- | | 5.2 | (All) | | IEC 62366-1:2015 Section | Document Section | | ------------------------ | ---------------- | | 5.1 | (All) | ## Product - Name: {{device_name}} - Version: {{device_version}} - Basic UDI-DI: N/A ## {{device_name}} Intended Use A Software as a Medical Device platform that supports patient treatment within the following use cases: - Clinical decision support within radiotherapy via automated contouring of both target and avoidance structures within the treatment planning workflow. - Patient alignment and setup support during radiotherapy treatments via patient surface guidance. - Treatment machine gating via patient surface tracking. - Alignment of radiotherapy simulation images into breathing phases to support the treatment workflow. The {{device_name}} intends to be a platform that supports the safe and effective translation of open source research into Clinical Software as Medical Devices. As such, it is expected that future regulatory submissions will include expansions on the above intended use where the surrounding documentation is also updated accordingly. ## Individual Components The {{device_name}} is split into separate components. Each component has its own documentation that covers the following items: - Intended medical indication - Contraindications - Patient population - User profile - Use Environment including software/hardware - Operating principle The documents for these individual components are the following: - [](autocontouring.md) - [](sgrt.md) ## Part of the Body / Type of Tissue Interacted With The device is stand-alone software. It does not come in contact with tissue or bodily fluids. ## Variants / Accessories This is stand-alone software and this is not applicable.