# K100552: Raystation Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Raysearch Laboratories AB
- Decided: Mar 12, 2010 after 14 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862643 (1987). 12 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083264: Rayautoplan 1.0, Raysearch Laboratories AB (2009) Summary page 1.
- K081281: Ocentra Masterplan 3.1 (Ocentra Brachy), Nucletron Corporation (2008) Summary page 1.

## Most influential descendants
- K120387: Raystation (2012), 22 descendants of its own
- K130617: Raystation (2013), 21 descendants of its own
- K140187: Ray Station (2014), 19 descendants of its own
- K141860: Raystation (2014), 17 descendants of its own
- K160093: RayStation (2016), 16 descendants of its own

## Recalls of this device
- Feb 14, 2014 · Class II · Z-1481-2014: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
- Feb 6, 2014 · Class II · Z-1307-2014: Potential for dose errors due to software program errors.
- Dec 6, 2011 · Not classified · Z-1317-2012: An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
- Oct 19, 2011 · Not classified · Z-0359-2012: The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Positi

## 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/K100552
Methodology: https://510kreport.com/methodology