# K170355: RayStation 6

- Pathway: 510(k) (Traditional)
- Applicant: RaySearch Laboratories AB (PUBL)
- Decided: Mar 2, 2017 after 24 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010975 (2001). 66 ancestors in all.
15 later devices descend from it; 2 cite 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)
- K160093: RayStation, RaySearch Laboratories AB (PUBL) (2016) Summary page 4.

## Most influential descendants
- 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
- K210645: RayStation 10.1 (2021), 5 descendants of its own

## Recalls of this device
- Jan 16, 2025 · Class II · Z-1193-2025: 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

## 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/K170355
Methodology: https://510kreport.com/methodology