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System, Planning, Radiation Therapy Treatment
FDA product code MUJ · Class 2 · Radiology
255
Registered devices
804
Adverse events
267
Recalls
257
510(k) clearances
Devices with this code
TomoH® Treatment Delivery System — Accuray IncorporatedAccuray Precision® Treatment Planning System — ACCURAY INCORPORATEDRayStation — Raysearch Laboratories AB (Publ)EPIgray — DOSISOFTSW, Legal Labelling Install Disk, 5.1.9 — Accuray IncorporatedRayCare — Raysearch Laboratories AB (Publ)RayCare — Raysearch Laboratories AB (Publ)Accuray Precision® Treatment Planning System — ACCURAY INCORPORATEDDose+ — Mvision AI OyEclipse Treatment Planning System — VARIAN MEDICAL SYSTEMS, INC.CORVUS 09 — Best NomosMonaco — ELEKTA, INC.RayStation — Raysearch Laboratories AB (Publ)RayStation — Raysearch Laboratories AB (Publ)RayCare — Raysearch Laboratories AB (Publ)MOZI TPS — Manteia Technologies Co.,Ltd.Onrad Treatment System — ACCURAY INCORPORATEDNA — Nucletron B.V.RayCare — Raysearch Laboratories AB (Publ)RayStation — Raysearch Laboratories AB (Publ)RT Elements — Brainlab SEPanther TPS — Prowess, Inc.RayStation — Raysearch Laboratories AB (Publ)RT Elements - RT QA — Brainlab SE
Recent 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
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