RayStation 9B SP1

• EUDAMED Basic UDI-DI B-07350002010297 registered 27 Oct 2026 Active
• FDA 510(k) K200569 decided 24 Sep 2020 Active
• FDA GUDID UDI-DI 07350002010297 listed 27 May 2021 Listed

• • Ongoing Z-2489-2025 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-1187-2025 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-1745-2024 FDA Class II ·initiated 28 Mar 2024
  • Ongoing Z-1746-2024 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-1427-2021 FDA Class II ·initiated 25 Mar 2021

  Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

• • Terminated Z-1403-2022 FDA Class II ·initiated 1 Jun 2022

  An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

• • Terminated Z-2138-2021 FDA Class II ·initiated 8 Jun 2021

  Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

• • Terminated Z-1838-2021 FDA Class II ·initiated 21 Apr 2021

  Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.

• • Terminated Z-1598-2021 FDA Class II ·initiated 7 Apr 2021

  When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

• • Terminated Z-1597-2021 FDA Class II ·initiated 22 Feb 2021

  For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

• • Terminated Z-2039-2023 FDA Class II ·initiated 22 Jan 2021

  A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

• • Terminated Z-0589-2021 FDA Class II ·initiated 11 Nov 2020

  Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

• • Terminated Z-0478-2021 FDA Class II ·initiated 8 Oct 2020

  If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

1. 21 Apr 2021 Recall initiated FDA recalls Z-1838-2021
2. 27 May 2021 Listed FDA GUDID 07350002010297
3. 8 Jun 2021 Recall initiated FDA recalls Z-2138-2021
4. 1 Jun 2022 Recall initiated FDA recalls Z-1403-2022
5. 23 Feb 2024 Recall initiated FDA recalls Z-1482-2024
6. 28 Mar 2024 Recall initiated FDA recalls Z-1745-2024
7. 28 Mar 2024 Recall initiated FDA recalls Z-1746-2024
8. 16 Jan 2025 Recall initiated FDA recalls Z-1187-2025
9. 8 Aug 2025 Recall initiated FDA recalls Z-2489-2025
10. 27 Oct 2026 Registered EUDAMED B-07350002010297

7 earlier events are in the sections above.

Trade name

RayStation 9B SP1 EUDAMED

RayStation GUDID

Generic name

Radiation therapy software

Model / reference

9.2 EUDAMED

9B SP1 GUDID

Primary DI / UDI-DI

07350002010297

Basic UDI-DI

B-07350002010297

510(k) Number

K200569 ↗

FDA product code

MUJ

EMDN code

Z11019082 Various radiotherapy and radiosurgery instruments - software accessories

GMDN term

Radiation therapy software

Device class

Class IIb EUDAMED

Class II GUDID

Regulation number

892.5050

System or procedure pack

System which is a device in itself

EU registration type

Legacy device (under a directive)

EU market of registration

Belgium

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Radiation therapy software

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