RayStation
29 catalogue numbers from 10B SP1, listed by RaySearch Laboratories AB (publ), Sweden, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
29catalogue numbers in this listing
15510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | RaySearch Laboratories AB (publ), Sweden |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K170355 |
| Record published | 2022-02-21 |
| Record revised | 2025-12-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-11-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10B SP1 | In distribution | |
| 11B SP1 | In distribution | |
| 6.0 | In distribution | |
| 8.1 | In distribution | |
| 11B | In distribution | |
| 11B SP2 | In distribution | |
| 11A SP2 | In distribution | |
| 6.2 | In distribution | |
| 12A | In distribution | |
| 2023B | In distribution | |
| 11.0.1 | In distribution | |
| 8.0.1 | In distribution | |
| 9B SP1 | In distribution | |
| 10.0.1 | In distribution | |
| 10.1 | In distribution | |
| 6.1 | In distribution | |
| 12A SP2 | In distribution | |
| 2024A SP3 | In distribution | |
| 10.0 | In distribution | |
| 11B SPT1 | In distribution | |
| 7 | In distribution | |
| 8.1.1 | In distribution | |
| 8.0 | In distribution | |
| 9 | In distribution | |
| 12A SP1 | In distribution | |
| 6.1.1 | In distribution | |
| 11.0 | In distribution | |
| 8.1.2 | In distribution | |
| 5.0.3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System, Planning, Radiation Therapy Treatment | Nucletron B.V. | 17 |
| Panther TPS | Prowess, Inc. | 14 |
| RayCare | RaySearch Laboratories AB (publ) | 12 |
| Accuray Precision® Treatment Planning System | Accuray Incorporated | 7 |
| Monaco | Elekta Inc. | 7 |
| Eclipse Treatment Planning System for External Beam Radiation Therapy | Varian Medical Systems, Inc | 6 |
| syngo.via RT Image Suite | Siemens Healthcare Limited | 5 |
| Eclipse Treatment Planning System | Varian Medical Systems, Inc | 5 |
| Corvus 09 | Best Nomos | 4 |
| Monaco | Elekta Solutions AB | 4 |
| XKnife® | Integra Lifesciences Corporation | 4 |
| Philips | Philips Medical Systems (Cleveland), Inc. | 4 |
Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252109 | 2025-12-22 |
| K242992 | 2025-04-17 |
| K240398 | 2025-04-04 |
| K222312 | 2023-03-29 |
| K220141 | 2022-04-15 |
| K211867 | 2021-09-08 |
| K210645 | 2021-06-29 |
| K200569 | 2020-09-24 |
| K200487 | 2020-06-10 |
| K191384 | 2019-07-08 |
| K190387 | 2019-06-19 |
| K180379 | 2018-04-25 |
| K171536 | 2017-06-27 |
| K170355 | 2017-03-02 |
| K160093 | 2016-04-08 |
Recalls Naming This Product
85 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| RaySearch Laboratories AB (publ) | UDI-DI | 2025-11-28 | Class II | Under Investigation by firm | 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 t | 0 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-11-28 | Class II | Under Investigation by firm | 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 t | 10 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-11-28 | Class II | Under Investigation by firm | 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 t | 22 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-11-28 | Class II | Under Investigation by firm | 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 t | 8 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-11-28 | Class II | Under Investigation by firm | 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 t | 119 | |
| RaySearch Laboratories AB (publ) | UDI-DI | 2025-11-28 | Class II | Under Investigation by firm | 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 t | 0 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 1 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 2 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 26 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 3 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 6 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 13 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 0 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 49 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 0 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 1 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 1 | |
| RaySearch Laboratories AB (publ) | UDI-DI | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 0 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 6 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 5 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 32 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 1 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 0 | |
| RaySearch Laboratories AB (publ) | UDI-DI | 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 0 | |
| RaySearch Laboratories AB (publ) | UDI-DI | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 14 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 9 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 5 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 63 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 11 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 213 units | |
| RaySearch Laboratories AB (publ) | UDI-DI | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 18 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 10 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 66 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 128 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 49 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2024-02-23 | Class II | Under Investigation by firm | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. | 154 units | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2023-02-17 | Class II | Under Investigation by firm | 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 expo | 10770 systems | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2022-06-10 | Class II | Under Investigation by firm | This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second | 26 | 2024-06-11 |
| RaySearch Laboratories AB (publ) | 510(k) number | 2022-06-01 | Class II | Software change control | 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. | 1 | 2023-10-04 |
| RaySearch Americas Inc. | 510(k) number | 2022-02-11 | Class II | Under Investigation by firm | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. | 653 (US 149, OUS 504) |
Showing 40 of 85.
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-05-20 | Class II | Under Investigation by firm | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. | 3 units |
| 2026-05-20 | Class II | Under Investigation by firm | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. | 3 units |
| 2025-11-28 | Class II | Under Investigation by firm | 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 t | 0 |
| 2025-11-28 | Class II | Under Investigation by firm | 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 t | 0 |
| 2025-11-28 | Class II | Under Investigation by firm | 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 t | 0 |
| 2025-08-08 | Class II | Under Investigation by firm | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray’s iDMS, are not guaranteed to be unique. | 3 |
| 2025-01-16 | Class II | Under Investigation by firm | 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 Ra | 0 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.