Product code MUJ
- Device name
- System, Planning, Radiation Therapy Treatment
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | 2026-05-22 |
| K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026-05-14 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| K250064 | Dose+ (1.0) | Mvision AI OY | 2025-09-04 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmen... | Brainlab AG | 2025-06-17 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| K242748 | Oncospace | Oncospace, Inc. | 2025-04-11 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025-02-25 |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024-12-13 |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024-12-11 |
| K240671 | XBeam (v2) | Xstrahl, Ltd. | 2024-12-04 |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024-10-23 |
| K241876 | Vitesse (5.0) | Varian Medical Systems | 2024-10-23 |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | 2024-08-30 |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | 2024-05-17 |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2024-04-26 |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | 2024-04-22 |
| K232479 | ART-Plan | Therapanacea | 2023-12-22 |
| K231825 | Panther TPS | Prowess, Inc. | 2023-12-15 |
| K232400 | VariSeed (v10) | Varian Medical Systems | 2023-09-08 |
| K223724 | MOZI TPS | Manteia Technologies Co., Ltd. | 2023-07-10 |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | 2023-05-26 |
| K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | 2023-05-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436567540024 | Radiance | GMV SOLUCIONES GLOBALES INTERNET SA | 2026-04-08 |
| 08717213053717 | NA | Nucletron B.V. | 2018-12-19 |
| 08717213053700 | NA | Nucletron B.V. | 2018-12-19 |
| M65810492110 | Onrad Treatment System | ACCURAY INCORPORATED | 2018-06-22 |
| 08717213052321 | NA | Nucletron B.V. | 2018-03-20 |
| 08717213052314 | NA | Nucletron B.V. | 2018-03-20 |
| 08436567540017 | radiance | GMV SOLUCIONES GLOBALES INTERNET SA | 2018-01-05 |
| 08717213052291 | NA | Nucletron B.V. | 2017-10-18 |
| 08717213052307 | NA | Nucletron B.V. | 2017-10-18 |
| M65810489680 | TomoTherapy® Treatment Delivery System | ACCURAY INCORPORATED | 2017-08-25 |
| 08717213052239 | NA | Nucletron B.V. | 2017-06-16 |
| 08717213052246 | NA | Nucletron B.V. | 2017-06-16 |
| 08717213051881 | NA | Nucletron B.V. | 2017-02-17 |
| 08436567540000 | radiance | GMV SOLUCIONES GLOBALES INTERNET SA | 2017-01-23 |
| 08717213051782 | NA | Nucletron B.V. | 2016-12-07 |
| 08717213051775 | NA | Nucletron B.V. | 2016-12-07 |
| 08717213038677 | NA | Nucletron B.V. | 2016-10-20 |
| 08717213020610 | NA | Nucletron B.V. | 2016-10-20 |
| 08717213038660 | NA | Nucletron B.V. | 2016-10-20 |
| 08717213051294 | NA | Nucletron B.V. | 2016-10-20 |
| M65810502420 | Accuray Precision® Treatment Planning System | ACCURAY INCORPORATED | 2016-09-22 |
| M65810525910 | Delivery Analysis TM | ACCURAY INCORPORATED | 2016-09-22 |
| M65810182860 | TomoHDA® Treatment Delivery System | Accuray Incorporated | 2016-09-22 |
| M65810182840 | TomoH® Treatment Delivery System | ACCURAY INCORPORATED | 2016-09-22 |
| M65810182830 | TomoHD® Treatment Delivery System | ACCURAY INCORPORATED | 2016-09-22 |
| 10381780252962 | XKnife® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780252955 | XKnife® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780252948 | XKnife® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780252931 | XKnife® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780252818 | CRW® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |