# K171536: RayStation

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Jun 27, 2017 after 33 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010975 (2001). 67 ancestors in all.
13 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)
- K170355: RayStation 6, RaySearch Laboratories AB (PUBL) (2017) Summary page 4.

## Most influential descendants
- K180379: RayStation 7 (2018), 12 descendants of its own
- 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

## Recalls of this device
- Aug 8, 2025 · Class II · Z-2494-2025: 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-1192-2025: 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, 2018 · Class II · Z-2290-2018: The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
- Jan 26, 2018 · Class II · Z-1275-2018: Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
- Nov 20, 2017 · Class II · Z-1930-2019: When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
- Jul 17, 2017 · Class II · Z-0380-2018: For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup

## 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/K171536
Methodology: https://510kreport.com/methodology