RayStation

• • Ongoing Z-2488-2025 FDA Class II ·initiated 8 Aug 2025

  DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

• • Ongoing Z-1186-2025 FDA Class II ·initiated 16 Jan 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 density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

• 2 recalls, same reason

  • Ongoing Z-1743-2024 FDA Class II ·initiated 28 Mar 2024
  • Ongoing Z-1744-2024 FDA Class II ·initiated 28 Mar 2024

  Potential for reported SSD to be too high.

• • Ongoing Z-1482-2024 FDA Class II ·initiated 23 Feb 2024

  A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

• • Ongoing Z-1281-2023 FDA Class II ·initiated 17 Feb 2023

  It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

• • Ongoing Z-2426-2020 FDA Class II ·initiated 26 May 2020

  It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

• • Ongoing Z-1598-2020 FDA Class II ·initiated 4 Mar 2020

  Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.

• 15 recalls, same reason

  • Terminated Z-2343-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2351-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2352-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2347-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2349-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2348-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2339-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2345-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2350-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2353-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2340-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2346-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2342-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2341-2020 FDA Class II ·initiated 18 May 2020
  • Terminated Z-2344-2020 FDA Class II ·initiated 18 May 2020

  Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

• 7 recalls, same reason

  • Terminated Z-1465-2020 FDA Class II ·initiated 20 Feb 2020
  • Terminated Z-1463-2020 FDA Class II ·initiated 20 Feb 2020
  • Terminated Z-1464-2020 FDA Class II ·initiated 20 Feb 2020
  • Terminated Z-1468-2020 FDA Class II ·initiated 20 Feb 2020
  • Terminated Z-1462-2020 FDA Class II ·initiated 20 Feb 2020
  • Terminated Z-1467-2020 FDA Class II ·initiated 20 Feb 2020
  • Terminated Z-1466-2020 FDA Class II ·initiated 20 Feb 2020

  There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

• • Terminated Z-0866-2020 FDA Class II ·initiated 19 Dec 2019

  Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.

• • Terminated Z-0736-2020 FDA Class II ·initiated 18 Nov 2019

  Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

1. 18 May 2020 Recall initiated FDA recalls Z-2342-2020
2. 18 May 2020 Recall initiated FDA recalls Z-2341-2020
3. 18 May 2020 Recall initiated FDA recalls Z-2344-2020
4. 26 May 2020 Recall initiated FDA recalls Z-2426-2020
5. 17 Feb 2023 Recall initiated FDA recalls Z-1281-2023
6. 23 Feb 2024 Recall initiated FDA recalls Z-1482-2024
7. 28 Mar 2024 Recall initiated FDA recalls Z-1743-2024
8. 28 Mar 2024 Recall initiated FDA recalls Z-1744-2024
9. 16 Jan 2025 Recall initiated FDA recalls Z-1186-2025
10. 8 Aug 2025 Recall initiated FDA recalls Z-2488-2025

23 earlier events are in the sections above.

510(k) Number

K190387 ↗

FDA product code

MUJ

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).

• RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review by Brainlab AG
• ECLIPSE WITH AAA by Varian Medical Systems, Inc
• VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM by VIEWRAY INCORPORATED
• DCM 1.0 by Mds Nordion, Inc.
• Monaco RTP System (6.3) by ELEKTA SOLUTIONS AB
• RAYSTATION VERSION 1.0 by Raysearch Laboratories AB
• RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE by Radionics, A Division of Tyco Healthcare Group LP
• syngo.via RT Image Suite by SIEMENS MEDICAL SOLUTIONS USA, INC.
• CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY by Accuray Incorporated
• CORVUS Radiation Therapy Planning System by Best Nomos

• RayStation 2024A SP1

  Class IIb

  CE/MDR

• RayStation 2024A

  Class IIb

  CE/MDR

• RayStation 2024B

  Class IIb

  CE/MDR

• RayStation 9B

  Class IIb

  CE/MDD

See all devices from RaySearch Laboratories AB (PUBL) →