# K180379: RayStation 7

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Apr 25, 2018 after 72 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K010975 (2001). 68 ancestors in all.
12 later devices descend from it; 1 cites 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)
- K171536: RayStation, RaySearch Laboratories AB (PUBL) (2017) Summary page 4.

## Most influential descendants
- K190387: RayStation (2019), 11 descendants of its own
- 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

## Recalls of this device
- Aug 8, 2025 · Class II · Z-2487-2025: 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-1185-2025: 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-1742-2024: Potential for reported SSD to be too high.
- Nov 12, 2018 · Class II · Z-0679-2019: Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter sh
- Sep 21, 2018 · Class II · Z-0294-2019: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
- Jun 29, 2018 · Class II · Z-2497-2018: If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially signif
- Jun 6, 2018 · Class II · Z-2554-2018: The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or

## 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/K180379
Methodology: https://510kreport.com/methodology