FDA-cleared profile
RaySearch Laboratories AB (publ)
RayStation 12A is configurable software for radiation therapy and medical oncology that proposes treatment plans from user input. Authorized users may use reviewed and approved plans to support treatment administration; the system includes image handling, contouring, treatment planning and optimization, dose calculation and evaluation, machine commissioning, treatment interfaces, and machine-learning segmentation or planning functions.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Validate every DICOM service, transfer profile, object mapping, treatment-machine interface, database dependency, and failure-recovery path in the local environment.
The environment guide warns that secure operation on Windows Server 2016 cannot be guaranteed after the end of NVIDIA R470 security support. Confirm the exact supported operating-system, GPU-driver, database, and patch matrix for the installed build.
Local governance should also include incident review, backup-restoration tests, interface reconciliation, performance baselines, access review, vulnerability response, change control, and FDA recall surveillance.
The FDA summary describes RayStation, RayPhysics, and RayTreat applications and separate Microsoft SQL patient, machine, and clinic databases.
exact submission · checked 2026-09-02Assign technical ownership for application servers, databases, storage, backups, treatment interfaces, and clinical configuration.
The 12A environment guide documents local desktop, centralized Citrix, shared application-server, and restricted virtual-machine designs using Windows clients, Microsoft SQL Server, and supported NVIDIA GPUs.
exact product version · checked 2026-09-02Size CPU, memory, GPU, storage, database, remote-display, and concurrency for the purchased modules and workload; confirm every component against the installed 12A build.
RayStation 12A imports CT, PET, and MR data and supports DICOM and DICOM RT exchange of images, structures, plans, and dose with connected clinical systems.
exact submission · checked 2026-09-02The IFU requires verification that DICOM export completed successfully. Include object-level reconciliation and treatment-machine end-to-end tests in acceptance.
Role-based Active Directory groups separate administration, beam commissioning, plan approval, and machine-learning administration; the guide also describes least privilege, encrypted communications and storage, protected backups, malware controls, account lockout, VPN or segmentation for legacy DICOM, and controlled remote access.
exact product version · checked 2026-09-02Translate vendor guidance into a site security design, access matrix, patch plan, vulnerability process, backup architecture, logging plan, and downtime procedure.
The IFU requires installation-specific acceptance after relevant hardware or software changes, local commissioning of machine-learning models, qualified-user review of automated segmentations, and genuinely independent dose verification.
exact product version · checked 2026-09-02Create signed acceptance protocols for each modality, machine, energy, technique, dose engine, model, script, interface, and report used clinically.
The environment guide calls for database backup and reindexing and monitoring of disk capacity, services, and processor utilization.
exact product version · checked 2026-09-02Define alert thresholds, owners, escalation, restoration tests, maintenance windows, capacity forecasts, and evidence retention.
RaySearch continues to market RayStation as a configurable treatment-planning platform spanning multiple treatment techniques and machine ecosystems and maintains versioned safety and performance documentation.
product family · checked 2026-09-02Map all current commercial claims, support terms, upgrade paths, and optional modules back to the exact licensed 12A configuration.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
This field has not been curated yet.
This field has not been curated yet.
Data points failing a 2% / 2 mm gamma comparison against the prior RayStation electron Monte Carlo implementation in Manufacturer electron dose-engine validation cases described in the K222312 summary.
Tested version: RayStation 12A electron Monte Carlo dose engine cleared in K222312Maximum averaged difference between measured and calculated absolute central-axis dose across tested collimators and algorithms in CyberKnife M6 fixed, Iris, and multileaf collimator beam-model commissioning and validation.
Tested version: RayStation CyberKnife module; software release not reportedMean proportion of points meeting 3% / 1 mm gamma criteria in Patient-specific QA plans across commissioned CyberKnife M6 collimator and dose-algorithm models.
Tested version: RayStation CyberKnife module; software release not reportedManufacturer software verification and validation with water-tank, phantom, prior-engine, published-reference, competing-system, and independent Monte Carlo comparisons across changed treatment-planning functions · Ocular planning, electron dose calculation, brachytherapy TG-43, automated field-in-field, Flexitron support, and other software changes; no patient cohort reported
exact submission · Tested version: RayStation 12A cleared in K222312 · Sponsor or vendor studyK222312
FDA found the verification and validation adequate for substantial equivalence. The summary does not establish patient outcomes.
Independent single-center paired dosimetric comparison in which each case was planned with RayStation 12A and Precision · 59 paired CyberKnife M6 plans: 39 brain-metastasis plans and 20 vertebral-metastasis plans
exact product version · Tested version: RayStation 12A CyberKnife module · n=59 · 1 site · Independent studyPMID 39698880
Target coverage was equivalent for brain cases and worse for vertebral cases; organ-at-risk sparing improved, conformity was lower, and optimization took longer. The authors reported no conflicts of interest.
Independent single-center beam-model commissioning and phantom validation of collapsed-cone and Monte Carlo calculations for fixed, Iris, and multileaf collimators · CyberKnife M6 water-tank, homogeneous and heterogeneous phantom, irregular-field, off-axis, and patient-specific QA measurements
product family · Tested version: RayStation CyberKnife module; software release not reported · 1 site · Independent studyPMID 35856911
Most measured-versus-calculated differences were within plus or minus 1%, with a 3.2% maximum at 19.5 cm depth. One author held an unrelated Accuray grant.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
total order including service contract · China
Observed 2025-03-04Vendor-announced product-family order for an advanced carbon-ion, proton, and photon center. It is not a RayStation 12A list price, excludes unknown allocation across licenses and services, and should not be transferred to another institution or configuration.
No separate named-product payment identified in the reviewed CMS Radiation Oncology Model page
Medicare · United StatesThis is payment context for radiation therapy services, not a comprehensive coding or coverage determination.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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.
Open, Classified
2026-01-16The FDA record names RayStation 12A builds 13.0.0.1547, 13.1.0.144, and 13.1.1.89. Verify installed build, correction status, and the vendor workaround.
Open, Classified
2025-09-02The FDA record names all three 12A builds. Sites should verify installed versions and the vendor correction or re-export workaround.
Open, Classified
2025-02-19The FDA record explicitly names the RayStation 12A builds. Applicability depends on particle planning and the installed CT calibration approach.
Open, Classified
2024-05-01Exact 12A build match. The FDA action directs users to verify critical SSD values with the Measure Tool and follow the vendor correction.
Open, Classified
2024-04-05RayStation 12A is explicitly included. Sites should verify material-assignment review controls and whether the affected material remains available in the installed release.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. The exact FDA summary, exact-version IFU and environment guide, current vendor product context, independent exact-version and product-family evidence, public pricing observation, CMS payment context, and every exact-identifier FDA recall candidate were manually reviewed. Product-specific contract pricing, local interoperability, installed options, and site qualification still require institution and vendor evidence. Automated exact-name discovery found 4 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 6 FDA recall candidates were manually reviewed: 5 published and 1 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 6 postmarket candidate records; 6 have been reviewed (5 published, 1 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, vendor instructions for use, vendor technical documentation, vendor product page, peer reviewed publication, vendor pricing observation, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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