RayCare
RayCare 3.1 is a software-only oncology information system that supports healthcare professionals in managing cancer care. The filing describes modules for patient clinical data, care…
RayCare 3.1 is a software-only oncology information system that supports healthcare professionals in managing cancer care. The filing describes modules for patient clinical data, care administration, clinical notes, workflow and task management, scheduling, and other healthcare-system functions.
Its intended role includes workflow and scheduling, clinical information, planning and treatment management across radiation, medical and surgical oncology. RayCare can transfer, store, convert and display patient data, but the filing states that it is not intended for diagnostic activities.
Clinical and Administrative Workflows
RayCare uses a client interface for user interaction and a server for processing and storage. The summary describes treatment-planning and delivery workflows, electronic patient charts, image review and archiving, and treatment-setup review.
5manufacturers in China registered for this device type
12catalogue 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) | K200487 |
| Record published | 2021-09-30 |
| Record revised | 2023-05-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Distribution end date | 2025-11-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5B SP1 | In distribution | |
| 2024A SP1 | In distribution | |
| 4.0 | In distribution | |
| 2024A SP4 | In distribution | |
| 4.1 | Withdrawn | |
| 5A SP1 | Withdrawn | |
| 3.0.1 | Withdrawn | |
| 5.0 | Withdrawn | |
| 2.3 | Withdrawn | |
| 4.1.1 | Withdrawn | |
| 3.0 | Withdrawn | |
| 3.1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RayStation | RaySearch Laboratories AB (publ) | 29 |
| System, Planning, Radiation Therapy Treatment | Nucletron B.V. | 17 |
| Panther TPS | Prowess, Inc. | 14 |
| 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
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| RaySearch Laboratories AB (publ) | 510(k) number | 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 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 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 | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2023-09-12 | Class II | Under Investigation by firm | An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selec | 2 sytems | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2023-07-17 | Class II | Under Investigation by firm | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances | 1 install | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2021-06-08 | Class II | Under Investigation by firm | Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. | 5 units | 2024-03-20 |
| RaySearch Laboratories AB (publ) | 510(k) number | 2021-03-03 | Class II | Software design | Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later | 1 unit | |
| RaySearch Laboratories AB (publ) | 510(k) number | 2020-07-29 | Class II | Under Investigation by firm | When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting th |
Recalls
38 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 |
|---|---|---|---|---|
| 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 |
| 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 | 10 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 | 119 |
| 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 | 8 |
| 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. | 26 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2025-08-08 | 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 |
| 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 |
| 2025-08-08 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 66 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 11 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 49 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 213 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 63 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 5 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 128 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 18 units |
| 2024-03-28 | Class II | Software design | Potential for reported SSD to be too high. | 9 units |
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.