# K141860: Raystation

- Pathway: 510(k) (Traditional)
- Applicant: Raysearch Laboratories AB
- Decided: Oct 23, 2014 after 105 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010975 (2001). 64 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140187: Ray Station, Raysearch Laboratories AB (2014) Summary page 4.

## Most influential descendants
- K160093: RayStation (2016), 16 descendants of its own
- K170355: RayStation 6 (2017), 15 descendants of its own
- K171536: RayStation (2017), 13 descendants of its own
- K180379: RayStation 7 (2018), 12 descendants of its own
- K190387: RayStation (2019), 11 descendants of its own

## Recalls of this device
- Jan 16, 2025 · Class II · Z-1195-2025: 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
- Feb 10, 2016 · Class II · Z-1712-2016: A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the st
- May 29, 2015 · Class II · Z-2785-2015: An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
- May 27, 2015 · Class II · Z-2457-2015: Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and 
- Mar 4, 2015 · Class II · Z-1310-2015: An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam mode

## 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/K141860
Methodology: https://510kreport.com/methodology