MUJ
- Product code
- MUJ
- Device name
- System, Planning, Radiation Therapy Treatment
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 257
510(k) clearances, last 3 years (29)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260750 | 2026-07-08 | Varian Medical Systems, Inc. | Virtual Cone (1.0) | |
| K253050 | 2026-06-18 | Informai | RadOncAI | |
| K260207 | 2026-05-27 | Philips Medical Systems Nederland B.V. | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | |
| K252784 | 2026-05-22 | Anatomical Geometry S.L. | eXaSkin Plus | FDA |
| K253078 | 2026-05-14 | Seetreat Pty, Ltd. | ART.1-US | |
| K252304 | 2026-03-18 | Varian Medical Systems, Inc. | syngo.via RT Image Suite VC10 | |
| K252002 | 2026-02-19 | Elekta Solutions AB | Monaco RTP System (6.3) | |
| K260308 | 2026-02-19 | Adaptiiv Medical Technologies, Inc. | TrueFit Bolus | |
| K253091 | 2025-12-23 | Therapanacea Sas | ART-Plan+ (v3.1.0) | |
| K252109 | 2025-12-22 | RaySearch Laboratories AB (PUBL) | RayStation (2024A SP3) | |
| K252863 | 2025-12-19 | Radformation, Inc. | ClearCalc Model RADCA V2.6 | |
| K250963 | 2025-11-20 | Cosylab Jsc, Control System Laboratory | PlanOne 1 | |
| K250064 | 2025-09-04 | Mvision AI OY | Dose+ (1.0) | |
| K250440 | 2025-06-17 | Brainlab AG | RT Elements (4.5); (Elements) Multiple Brain Mets S | |
| K242992 | 2025-04-17 | RaySearch Laboratories AB (PUBL) | RayCare (2024A SP1) | |
| K242748 | 2025-04-11 | Oncospace, Inc. | Oncospace | |
| K240398 | 2025-04-04 | RaySearch Laboratories AB (PUBL) | RayStation 2023B, RayPlan 2023B, RayStation 2024A, R | |
| K242822 | 2025-02-25 | Therapanacea Sas | ART-Plan+ (v.3.0.0) | |
| K242463 | 2024-12-13 | Varian Medical Systems, Inc. | ARIA Radiation Therapy Management System (18.1) | |
| K242378 | 2024-12-11 | Varian Medical Systems | Eclipse Treatment Planning System (18.1) | |
| K240671 | 2024-12-04 | Xstrahl, Ltd. | XBeam (v2) | |
| K243057 | 2024-10-23 | Adaptiiv Medical Technologies, Inc. | TrueFit Bolus; TrueFlex Bolus | |
| K241876 | 2024-10-23 | Varian Medical Systems | Vitesse (5.0) | |
| K241318 | 2024-08-30 | Adaptiiv Medical Technologies, Inc. | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | |
| K233236 | 2024-05-17 | Gmv Soluciones Globales Internet S.A.U | Radiance V5 | |
| K232799 | 2024-04-26 | Siemens Medical Solutions USA, Inc. | syngo.via RT Image Suite | |
| K234068 | 2024-04-22 | Therapanacea Sas | ART-Plan (v.2.2.0) | |
| K232479 | 2023-12-22 | Therapanacea | ART-Plan | |
| K231825 | 2023-12-15 | Prowess, Inc. | Panther TPS |
Official FDA classification page: MUJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).