# K160093: RayStation

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Apr 8, 2016 after 80 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: 10 generations back to K010975 (2001). 65 ancestors in all.
16 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)
- K141860: Raystation, Raysearch Laboratories AB (2014) Summary page 4.

## Most influential descendants
- 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
- K200569: RayStation (2020), 6 descendants of its own

## Recalls of this device
- Jan 16, 2025 · Class II · Z-1194-2025: 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
- Jan 18, 2017 · Class II · Z-1815-2017: An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citri
- Nov 9, 2016 · Class II · Z-0721-2017: Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air
- Oct 11, 2016 · Class II · Z-0720-2017: An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Ref
- Sep 1, 2016 · Class II · Z-0038-2017: RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose c
- Jul 1, 2016 · Class II · Z-2206-2016: An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an
- May 30, 2016 · Class II · Z-0079-2017: For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a re

## 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/K160093
Methodology: https://510kreport.com/methodology