RayStation 10.1

Evidence summary

The K210645 FDA decision summary describes system, software, user, unit, dose, treatment-planning, and workflow validation for RayStation 10.1, including medical-oncology and radiation-treatment planning additions. The public package does not establish a general diagnostic-classifier sensitivity or specificity claim.

FDA source Exact FDA submission Checked 2026-09-03

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No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

6 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K210645. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-1102-2026 is Open, Classified for RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System. FDA reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. FDA action: RaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. The upgrade to an unaffected software version will be scheduled in coordination with the authorized personnel, considering the specific circumstances and requirements of each individual case. The upgrade may be conducted remotely or onsite, as deemed appropriate. FDA recall Z-2490-2025 is Open, Classified for RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.. FDA reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. FDA action: RaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. FDA recall Z-1188-2025 is Open, Classified for Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1. FDA reason: 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. FDA action: Raysearch issued Field Safety Notice, Medical Device Correction #148655 RayStation version 4.5 to 2024B including some service packs via email on 1/17/25. Letter states reason for recall, health risk and action to take: For users of HU-to-mass density CT calibration curves If a user wants to evaluate a plan with respect to relative stopping power/WE range error rather than mass density errors, there are two options: Option 1. Use a HU-to-SPR CT calibration curve instead of a HU-to-mass density curve. " For evaluation of an existing case, the evaluation can be done on an anonymized and exported copy of the patient and plan. " Contact RaySearch Service if you need help with the creation of a HU-to-SPR curve from an existing HU-to-mass density curve. Option 2. Evaluate the plan using a higher (effective) mass density uncertainty that gives similar relative stopping power and WE range change as the nominal value. " The following values of Effective mass density errors that give similar result as an intended Stopping power error have been deduced from a limited set of patients: " For other values of intended Stopping power error, interpolate the approximate Effective mass density value from the table above. " The values are estimates based on a few patients and are expected to vary slightly depending on the mass densities along the beam path. " Note that the values are not symmetrical around 0. For users of HU-to-SPR CT calibration curves Be aware that the density uncertainty given in Robust evaluation, Compute perturbed dose and Robust optimization is used directly to scale stopping power and therefore WE range.... FDA recall Z-1747-2024 is Open, Classified for RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.. FDA reason: Potential for reported SSD to be too high. FDA action: A Field Safety Notice for Medical Device Correction #133261, dated 3/28/24, was sent to consignees via email. Consignees were provided the instructions to use the Measure Tool to measure the distance in the patient view to make sure the reported SSD value is correct if it is to be used for patient setup or other critical tasks. If the SSD value is found to be incorrect, small changes to the isocenter, beam angles or the affected ROI's geometry can be made until the correct value is achieved. Consignees are to inform planning staff and all users of the workarounds provided in the Field Safety Notice. Consignees are to inspect their product and identify if installed units possess the affected software versions. Consignees are to reply to the recall notification confirming that they read and understood the Field Safety Notificaiton. RaySearch is to deploy a new version of RayStation/RayPlan to correct the issue, to be released in April 2024. The provided Field Safety Notice is to be maintained with affected units. Consignees with any questions are to contact quality@raysearchlabs.com. FDA recall Z-1482-2024 is Open, Classified for RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.. FDA reason: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. FDA action: On February 26, 2024, the firm notified customers of the issue via Urgent Field Safety Notice: Medical Device Correction letters via email. Actions to be taken by the user: 1. Educate planning staff and all users about the possibility of the described use error. 2. If the use error is deemed likely to occur at your clinic, take actions to ensure that proper review of assigned materials is performed before a patient model is used for treatment planning. 3. If you wish to have the Silicon chemical element removed from the material list, contact RaySearch support for assistance. This is especially recommended for clinics that perform ion beam treatments, where the harm caused by the use error could be significant. 4. Inspect your product and identify all installed units with the above software version number(s). 5. Confirm you have read and understood this notice by replying to the notification email. The Silicon chemical element will not be included in the next version of RayStation/RayPlan, scheduled for market release in April 2024 (subject to market clearance in some markets). If requested by the customer, it can be removed from the material list of existing installations. This notice needs to be passed on to all those who need to be aware within your organization. Maintain awareness of this notice as long as any affected version is in use. Thank you for your cooperation, and we apologize for any inconvenience. For regulatory information, please contact quality@raysearchlabs.com. FDA recall Z-0848-2022 is Terminated for TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.. FDA reason: If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning FDA action: RaySearch issued Field Safety Notice, Medical Device Correction #83773 notice via email on Sept. 9, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY THE USER " Avoid changing the dose grid after starting an optimization of TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after editing the dose grid for TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after modifying the target ROI. " It is recommended to use the BEV to inspect the jaw positions superior and inferior to the target dynamic jaw mode. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in October 2021 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. For regulatory information, please contact quality@raysearchlabs.com.

FDA source Exact FDA submission 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.

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• Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 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: 6 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 6 postmarket candidate records; 6 have been reviewed (6 published, 0 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision summary K210645: RayStation 10.1 U.S. Food and Drug Administration · 2026-09-03
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-1102-2026: RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2490-2025: RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1188-2025: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1747-2024: RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1482-2024: RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-0848-2022: TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29. U.S. Food and Drug Administration · 2026-09-04
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Radiation Oncology Model Centers for Medicare & Medicaid Services · 2026-09-02
• RaySearch RayStation product family RaySearch Laboratories · 2026-09-03
• RayStation safety and performance information RaySearch Laboratories · 2026-09-03