MUJ
- 产品代码
- MUJ
- 器械名称
- System, Planning, Radiation Therapy Treatment
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.5050
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 257 件
该代码近三年的 510(k)（29 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260750 | 2026-07-08 | Varian Medical Systems, Inc. | Virtual Cone (1.0) 摘要 |
| K253050 | 2026-06-18 | Informai | RadOncAI 摘要 |
| K260207 | 2026-05-27 | Philips Medical Systems Nederland B.V. | Multimodality Simulation Workspace (MM Sim) (v1.0.0) 摘要 |
| K252784 | 2026-05-22 | Anatomical Geometry S.L. | eXaSkin Plus 摘要 |
| K253078 | 2026-05-14 | Seetreat Pty, Ltd. | ART.1-US 摘要 |
| K252304 | 2026-03-18 | Varian Medical Systems, Inc. | syngo.via RT Image Suite VC10 摘要 |
| K252002 | 2026-02-19 | Elekta Solutions AB | Monaco RTP System (6.3) 摘要 |
| K260308 | 2026-02-19 | Adaptiiv Medical Technologies, Inc. | TrueFit Bolus 摘要 |
| K253091 | 2025-12-23 | Therapanacea Sas | ART-Plan+ (v3.1.0) 摘要 |
| K252109 | 2025-12-22 | RaySearch Laboratories AB (PUBL) | RayStation (2024A SP3) 摘要 |
| K252863 | 2025-12-19 | Radformation, Inc. | ClearCalc Model RADCA V2.6 摘要 |
| K250963 | 2025-11-20 | Cosylab Jsc, Control System Laboratory | PlanOne 1 摘要 |
| K250064 | 2025-09-04 | Mvision AI OY | Dose+ (1.0) 摘要 |
| K250440 | 2025-06-17 | Brainlab AG | RT Elements (4.5); (Elements) Multiple Brain Mets S 摘要 |
| K242992 | 2025-04-17 | RaySearch Laboratories AB (PUBL) | RayCare (2024A SP1) 摘要 |
| K242748 | 2025-04-11 | Oncospace, Inc. | Oncospace 摘要 |
| K240398 | 2025-04-04 | RaySearch Laboratories AB (PUBL) | RayStation 2023B, RayPlan 2023B, RayStation 2024A, R 摘要 |
| K242822 | 2025-02-25 | Therapanacea Sas | ART-Plan+ (v.3.0.0) 摘要 |
| K242463 | 2024-12-13 | Varian Medical Systems, Inc. | ARIA Radiation Therapy Management System (18.1) 摘要 |
| K242378 | 2024-12-11 | Varian Medical Systems | Eclipse Treatment Planning System (18.1) 摘要 |
| K240671 | 2024-12-04 | Xstrahl, Ltd. | XBeam (v2) 摘要 |
| K243057 | 2024-10-23 | Adaptiiv Medical Technologies, Inc. | TrueFit Bolus; TrueFlex Bolus 摘要 |
| K241876 | 2024-10-23 | Varian Medical Systems | Vitesse (5.0) 摘要 |
| K241318 | 2024-08-30 | Adaptiiv Medical Technologies, Inc. | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) 摘要 |
| K233236 | 2024-05-17 | Gmv Soluciones Globales Internet S.A.U | Radiance V5 摘要 |
| K232799 | 2024-04-26 | Siemens Medical Solutions USA, Inc. | syngo.via RT Image Suite 摘要 |
| K234068 | 2024-04-22 | Therapanacea Sas | ART-Plan (v.2.2.0) 摘要 |
| K232479 | 2023-12-22 | Therapanacea | ART-Plan 摘要 |
| K231825 | 2023-12-15 | Prowess, Inc. | Panther TPS 摘要 |
FDA 官方分类页： MUJ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。