# K190387: RayStation

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Jun 19, 2019 after 120 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K010975 (2001). 69 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180379: RayStation 7, RaySearch Laboratories AB (PUBL) (2018) Summary page 4.

## Most influential descendants
- K200569: RayStation (2020), 6 descendants of its own
- K210645: RayStation 10.1 (2021), 5 descendants of its own
- K211867: RayStation 11.0 (2021), 4 descendants of its own
- K220141: RayStation 11B (2022), 3 descendants of its own
- K202789: Monaco Rtp System (2021), 3 descendants of its own

## Recalls of this device
- Aug 8, 2025 · Class II · Z-2488-2025: 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-1186-2025: 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-1744-2024: Potential for reported SSD to be too high.
- Mar 28, 2024 · Class II · Z-1743-2024: 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 17, 2023 · Class II · Z-1281-2023: It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button,
- May 26, 2020 · Class II · Z-2426-2020: It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of pla
- May 18, 2020 · Class II · Z-2343-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2351-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2341-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2352-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2342-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2344-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2348-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2349-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2340-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2350-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2353-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2347-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2346-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2339-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- May 18, 2020 · Class II · Z-2345-2020: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- Mar 4, 2020 · Class II · Z-1598-2020: Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than th
- Feb 20, 2020 · Class II · Z-1462-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Feb 20, 2020 · Class II · Z-1468-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Feb 20, 2020 · Class II · Z-1467-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Feb 20, 2020 · Class II · Z-1463-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Feb 20, 2020 · Class II · Z-1465-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Feb 20, 2020 · Class II · Z-1466-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Feb 20, 2020 · Class II · Z-1464-2020: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or ro
- Dec 19, 2019 · Class II · Z-0866-2020: Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue 
- Nov 18, 2019 · Class II · Z-0736-2020: Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan 

## Indications for use
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.

Source page: https://510kreport.com/device/K190387
Methodology: https://510kreport.com/methodology