# K211867: RayStation 11.0

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Sep 8, 2021 after 84 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K010975 (2001). 126 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210645: RayStation 10.1, RaySearch Laboratories AB (PUBL) (2021). Cleared while this submission was under review Summary page 6.

## Most influential descendants
- K220141: RayStation 11B (2022), 3 descendants of its own
- K222312: RayStation 12A (2023), 2 descendants of its own
- K240398: RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (2025), 1 descendant of its own
- K252109: RayStation (2024A SP3) (2025), 0 descendants of its own

## Recalls of this device
- Nov 28, 2025 · Class II · Z-1103-2026: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have 
- Aug 8, 2025 · Class II · Z-2491-2025: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- Jan 16, 2025 · Class II · Z-1189-2025: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass
- Mar 28, 2024 · Class II · Z-1748-2024: Potential for reported SSD to be too high.
- Feb 23, 2024 · Class II · Z-1482-2024: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
- Feb 11, 2022 · Class II · Z-0850-2022: Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
- Dec 30, 2021 · Class II · Z-0732-2022: If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true
- Sep 22, 2021 · Class II · Z-0849-2022: An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in 

## Indications for use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

Source page: https://510kreport.com/device/K211867
Methodology: https://510kreport.com/methodology