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MUJ

System, Planning, Radiation Therapy Treatment

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)
29 件
其中 Summary 已存档
28 份,可直接下载
FDA 历史累计 510(k)
257 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(29 件)

数据窗口为最近三年。最新一件:2026-07-08。

510(k) 号批准日期申请人器械名称摘要
K2607502026-07-08Varian Medical Systems, Inc.Virtual Cone (1.0)PDF
K2530502026-06-18InformaiRadOncAIPDF
K2602072026-05-27Philips Medical Systems Nederland B.V.Multimodality Simulation Workspace (MM Sim) (v1.0.0)PDF
K2527842026-05-22Anatomical Geometry S.L.eXaSkin PlusFDA
K2530782026-05-14Seetreat Pty, Ltd.ART.1-USPDF
K2523042026-03-18Varian Medical Systems, Inc.syngo.via RT Image Suite VC10PDF
K2520022026-02-19Elekta Solutions ABMonaco RTP System (6.3)PDF
K2603082026-02-19Adaptiiv Medical Technologies, Inc.TrueFit BolusPDF
K2530912025-12-23Therapanacea SasART-Plan+ (v3.1.0)PDF
K2521092025-12-22RaySearch Laboratories AB (PUBL)RayStation (2024A SP3)PDF
K2528632025-12-19Radformation, Inc.ClearCalc Model RADCA V2.6PDF
K2509632025-11-20Cosylab Jsc, Control System LaboratoryPlanOne 1PDF
K2500642025-09-04Mvision AI OYDose+ (1.0)PDF
K2504402025-06-17Brainlab AGRT Elements (4.5); (Elements) Multiple Brain Mets S…PDF
K2429922025-04-17RaySearch Laboratories AB (PUBL)RayCare (2024A SP1)PDF
K2427482025-04-11Oncospace, Inc.OncospacePDF
K2403982025-04-04RaySearch Laboratories AB (PUBL)RayStation 2023B, RayPlan 2023B, RayStation 2024A, R…PDF
K2428222025-02-25Therapanacea SasART-Plan+ (v.3.0.0)PDF
K2424632024-12-13Varian Medical Systems, Inc.ARIA Radiation Therapy Management System (18.1)PDF
K2423782024-12-11Varian Medical SystemsEclipse Treatment Planning System (18.1)PDF
K2406712024-12-04Xstrahl, Ltd.XBeam (v2)PDF
K2430572024-10-23Adaptiiv Medical Technologies, Inc.TrueFit Bolus; TrueFlex BolusPDF
K2418762024-10-23Varian Medical SystemsVitesse (5.0)PDF
K2413182024-08-30Adaptiiv Medical Technologies, Inc.Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)PDF
K2332362024-05-17Gmv Soluciones Globales Internet S.A.U…Radiance V5PDF
K2327992024-04-26Siemens Medical Solutions USA, Inc.syngo.via RT Image SuitePDF
K2340682024-04-22Therapanacea SasART-Plan (v.2.2.0)PDF
K2324792023-12-22TherapanaceaART-PlanPDF
K2318252023-12-15Prowess, Inc.Panther TPSPDF

其中 28 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。