RayStation 8.1, marketed as RayStation 8B, is configurable radiation therapy treatment-planning and analysis software. It imports patient images, supports contouring, image fusion, dose calculation, optimization and plan evaluation, and exports approved treatment plans with dose, structure, and image data for treatment.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
RayStation 8.1, marketed as RayStation 8B, is configurable radiation therapy treatment-planning and analysis software. It imports patient images, supports contouring, image fusion, dose calculation, optimization and plan evaluation, and exports approved treatment plans with dose, structure, and image data for treatment.
FDA source Exact FDA submission Checked 2026-09-02
Treatment-planning workstation used after image acquisition to create and review patient geometry, optimize beams, calculate dose, inspect two- and three-dimensional dose displays and dose-volume histograms, approve a plan, and export approved treatment objects.
FDA source Exact FDA submission Checked 2026-09-02
Patient CT data and, where used, registered PET or MR images; user-defined regions of interest, treatment-machine data, prescription and optimization objectives, and other planning parameters.
FDA source Exact FDA submission Checked 2026-09-02
Reviewed treatment plans, calculated dose distributions, structures, images, setup parameters, two- and three-dimensional plan displays, and dose-volume histograms; approved DICOM treatment objects can be exported for downstream use.
FDA source Exact FDA submission Checked 2026-09-02
A proposed plan must be reviewed and approved by authorized, clinically qualified users before treatment. The clearance establishes substantial equivalence and manufacturer verification and validation, not independent proof of patient outcomes or suitability for a site's machines, protocols, interfaces, and commissioned beam models.
FDA source Exact FDA submission Checked 2026-09-02
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K190387
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The FDA summary describes DICOM import of CT images, multimodality registration with PET and MR, interfacing with a treatment console, and DICOM export of approved plans, dose, structures, and images to a DICOM server.
FDA source Exact FDA submission Checked 2026-09-02
Confirm exact supported DICOM services, treatment-machine interfaces, transfer checks, interface ownership, and installed service-pack compatibility during local validation.
Software treatment-planning system deployed in the radiation oncology technical environment and connected to imaging, DICOM storage, and treatment-delivery workflows configured by the institution.
FDA source Exact FDA submission Checked 2026-09-02
The reviewed FDA summary does not specify a transferable hardware, server, database, virtualization, or high-availability architecture for every 8B installation.
Reviewed sources checked Exact product version Checked 2026-09-02
No exact RayStation 8B cybersecurity architecture or supported-platform security guide was established from the reviewed public sources. Obtain the version-specific security, patching, identity, encryption, audit, remote-access, backup, and vulnerability-management documentation.
Training and support
The FDA-cleared intended-user statement requires clinically qualified radiation therapy staff who are appropriately trained in system use.
FDA source Exact FDA submission Checked 2026-09-02
Procurement should define role-based training, competency assessment, commissioning privileges, plan-approval privileges, service-pack retraining, and support escalation.
Reviewed sources checked Exact product version Checked 2026-09-02
The reviewed public sources do not define an exact 8B operational monitoring program. Require local dose-calculation commissioning, end-to-end testing, DICOM transfer checks, machine and beam-model change control, backup testing, service-pack regression testing, incident review, and recall surveillance.
DICOM planning workflow
Imports CT, supports PET and MR registration, and exports approved plans, dose, structures, and images to a DICOM server after plan review.
exact submission · checked 2026-09-02
Perform conformance review and end-to-end testing for every scanner, PACS, oncology information system, treatment console, and transfer path.
The FDA summary describes contouring, image fusion, collapsed-cone dose calculation, four-dimensional compatibility, optimization, dose tracking and adaptation, deformable registration, machine-learning planning, and machine-learning segmentation.
exact submission · checked 2026-09-02
License, commissioning, validation, user privileges, and clinical scope should be mapped function by function; inclusion in the clearance summary does not mean every site has every option enabled.
RaySearch continues to market RayStation as a configurable treatment-planning platform spanning multiple treatment techniques and machine ecosystems.
product family · checked 2026-09-02
Current product-family features, hardware requirements, cybersecurity controls, and commercial terms must not be assumed to apply to an installed 8B release.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Manufacturer nonclinical verification and validation supported the 510(k). An independent hospital study found generally close agreement between measured data and RayStation's VMC++ electron Monte Carlo calculations, but did not report the software version and did not assess clinical outcomes.
Needs research Exact FDA submission Checked 2026-08-31
This field has not been curated yet.
Reported specificity
Research pending
Needs research Exact FDA submission Checked 2026-08-31
This field has not been curated yet.
Electron output factors within 3% of measurement
141 of 170 output factors
Calculated output factors within plus or minus 3% of measured values in Water-tank and clinically relevant electron-beam geometries across 6 to 18 MeV.
Tested version: RayStation VMC++ electron Monte Carlo; software release not reported
Calculated output factors within plus or minus 5% of measured values in Water-tank and clinically relevant electron-beam geometries across 6 to 18 MeV.
Tested version: RayStation VMC++ electron Monte Carlo; software release not reported
Evaluation of the RayStation electron Monte Carlo dose calculation algorithm
Independent single-center dosimetric validation against measured percentage-depth-dose, profile, heterogeneity, oblique-incidence, and output-factor data · Varian TrueBeam electron beams from 6 to 18 MeV in water-tank and clinically relevant phantom geometries
product family · Tested version: RayStation VMC++ electron Monte Carlo; software release not reported · n=170 · 1 site · Independent study
PMID 31629601
The publication reports no conflict of interest. Product-family evidence is not proof of equivalence to the exact 8B build, local beam model, machine, or protocol.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
No public price for RayStation 8B was found. A 2025 vendor announcement reports a RMB 51 million RayStation order including a service contract for a Chinese carbon-ion center; this is a product-family, bundled institutional benchmark and is not an 8B list price or a transferable quote.
CMS describes payment for professional and technical radiation therapy services, not a separate payment assigned to named treatment-planning software. The reviewed source does not support treating RayStation as independently reimbursed; local payer, contract, and service-line analysis remains necessary.
Vendor-announced product-family order for a carbon-ion center. It is not a RayStation 8B list price, excludes unknown allocation across licenses and services, and should not be transferred to another institution or configuration.
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
FDA recall Z-2488-2025 includes RayStation 8B and its first two service packs. DICOM objects exported through the RayGateway interface to Accuray iDMS were not guaranteed to receive unique SOP Instance and Series Instance UIDs. FDA lists the recall as open and classified. FDA recall Z-1186-2025 includes RayStation 8B and its first two service packs. It concerns inconsistent interpretation of density uncertainty in robust optimization, robust evaluation, and perturbed-dose calculations for proton and light-ion plans using an HU-to-mass-density calibration curve. FDA lists the recall as open and classified. FDA recall Z-1743-2024 affects RayStation 8B builds 8.1.0.47, 8.1.1.8, and 8.1.2.5 because the reported source-to-surface distance could be too high. FDA lists the recall as open and classified. FDA recall Z-1482-2024 includes RayStation 8B. It addresses a use error in which elemental silicon could be selected instead of silicone gel polymer as an implant material override, with potentially greater consequence for ion-beam planning. FDA lists the recall as open and classified. FDA recall Z-2426-2020 includes RayStation 8B and concerns treatment-record handling with RayCare PACS and RayTreat, including manual-import propagation and display of planned versus delivered gantry angles. FDA lists the recall as open and classified. FDA recall Z-2346-2020 affected RayStation 8B because a pencil-beam or line-scanning dose-calculation error could locally underestimate expected dose. FDA lists the recall as terminated. FDA recall Z-2347-2020 affected RayStation 8B SP1 because a pencil-beam or line-scanning dose-calculation error could locally underestimate expected dose. FDA lists the recall as terminated. FDA recall Z-2348-2020 affected RayStation 8B SP2 because a pencil-beam or line-scanning dose-calculation error could locally underestimate expected dose. FDA lists the recall as terminated. FDA recall Z-1598-2020 includes RayStation 8.1 and concerns Siemens Virtual Wedge fields whose opening could exceed the treatment-machine vendor recommendation, potentially producing a high-dose plateau. FDA lists the recall as open and classified. FDA recall Z-1464-2020 affected RayStation or RayPlan 8B build 8.1.0.47 because tabletop positions could propagate incorrectly when pitch or roll correction was applied. FDA lists the recall as terminated. FDA recall Z-1465-2020 affected RayStation or RayPlan 8B SP1 build 8.1.1.8 because tabletop positions could propagate incorrectly when pitch or roll correction was applied. FDA lists the recall as terminated. FDA recall Z-1466-2020 affected RayStation or RayPlan 8B SP2 build 8.1.2.5 because tabletop positions could propagate incorrectly when pitch or roll correction was applied. FDA lists the recall as terminated. FDA recall Z-0866-2020 includes RayStation 8.1 and addresses three issues involving ROI mapping geometry, Elekta guard-leaf interoperability, and source-to-surface-distance handling. FDA lists the recall as terminated. FDA recall Z-0736-2020 includes RayStation 8.1 because editing a static arc beam could reset monitor units to the default 200 MU, requiring dose recalculation before approval or export. FDA lists the recall as terminated.
FDA source Exact product version Checked 2026-09-04
Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.
The FDA record names RayStation 8B versions 8.1.0.47, 8.1.1.8, and 8.1.2.5. Sites should verify installed versions and the vendor correction or re-export workaround.
RayStation 8B is explicitly included. Sites should verify material-assignment review controls and whether the affected material remains available in the installed release.
Exact RayStation 8B match. The FDA action described Monte Carlo or geometry-related workarounds; verify correction status and local particle-planning exposure.
Verify security and privacy controls: No exact RayStation 8B cybersecurity architecture or supported-platform security guide was established from the reviewed public sources. Obtain the version-specific security, patching, identity, encryption, audit, remote-access, backup, and vulnerability-management documentation.
Verify local validation and lifecycle monitoring: The reviewed public sources do not define an exact 8B operational monitoring program. Require local dose-calculation commissioning, end-to-end testing, DICOM transfer checks, machine and beam-model change control, backup testing, service-pack regression testing, incident review, and recall surveillance.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
22Fields reviewed
10Source classes checked
20Unreviewed PubMed leads
5Unreviewed trial leads
0Unreviewed FDA recall leads
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. The exact FDA summary, current vendor product context, peer-reviewed product-family dosimetry evidence, public pricing observation, CMS payment context, and every exact-identifier FDA recall candidate were manually reviewed. Security and operational-monitoring details remain explicitly unresolved for the exact 8B release rather than being inferred from later documentation. Automated exact-name discovery found 20 PubMed and 5 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 32 FDA recall candidates were manually reviewed: 14 published and 18 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 32 postmarket candidate records; 32 have been reviewed (14 published, 18 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, peer reviewed publication, vendor product page, vendor pricing observation, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
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