Dose+
Mvision AI Oy · Model 1.0 · UDI-DI 06429830064237
Description
Dose+ is a software-only medical device intended for use by qualified, trained radiation therapy professionals (including but not limited to medical physicists, radiation oncologists, and medical dosimetrists). The device is intended for male patients with localized prostate cancer or prostate cancer with pelvic lymph node involvement who are undergoing external beam radiation therapy treatment. The software uses machine learning-based algorithms to automatically produce 3D dose distributions from patient-specific anatomical geometry and target dose prescription. The predicted dose distribution output is required to be transferred to a radiotherapy treatment planning system (TPS) or reviewed by any DICOM-RT compliant software prior to further use in clinical workflows. Dose+ is intended to provide additional information during the treatment planning process facilitating the creation and review of a treatment plan. Dose+ is not intended to be used for disease diagnosis and treatment decision purposes in clinical workflows
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-20 | RAYSEARCH LABORATORIES AB | 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, |
| 2026-05-20 | RAYSEARCH LABORATORIES AB | 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, |
| 2025-12-12 | Elekta, Inc. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea |
| 2025-12-12 | Elekta, Inc. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | 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 conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | 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 conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | 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 conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | 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 conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | 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 conto |
| 2025-11-28 | RAYSEARCH LABORATORIES AB | 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 conto |
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