# Raystation Version 1.0

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/raystation-version-1-0-muj>
- Manufacturer: [Raysearch Laboratories AB](https://devicerts.com/manufacturers/raysearch-laboratories-ab) (Sweden, FDA 510(k) applicant)
- Name in the registry: RAYSTATION VERSION 1.0
- Device class: Class II (US FDA)
- FDA product code: MUJ

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K100552 · decision 2010-03-12 · decision SESE · status: Active

## Recalls

- Z-1481-2014 · Class II · terminated · initiated 2014-02-14: 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.
- Z-1307-2014 · Class II · terminated · initiated 2014-02-06: Potential for dose errors due to software program errors.
- Z-1317-2012 ·  · terminated · initiated 2011-12-06: 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.
- Z-0359-2012 ·  · terminated · initiated 2011-10-19: 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 Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.

## Identifiers

- 510(k) Number: K100552 [FDA 510(k)]
- FDA product code: MUJ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.5050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Raystation Version 1.0, Raysearch Laboratories AB. deviCERTS medical device catalogue. https://devicerts.com/devices/raystation-version-1-0-muj (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/raystation-version-1-0-muj.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/raystation-version-1-0-muj
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.