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KPS

System, Tomography, Computed, Emission

产品代码
KPS
器械名称
System, Tomography, Computed, Emission
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 892.1200
FDA 专业组
Radiology
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
32 件
其中 Summary 已存档
30 份,可直接下载
FDA 历史累计 510(k)
472 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)(32 件)

数据窗口为最近三年。最新一件:2026-07-28。

510(k) 号批准日期申请人器械名称摘要
K2614272026-07-28Shanghai United Imaging Healthcare Co.…uMI Panvivo (uMI Panvivo M)PDF
K2613152026-05-21Siemens Medical Solutions USA, Inc.Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3…FDA
K2605242026-04-03Shanghai United Imaging Healthcare Co.…uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvi…FDA
K2535642026-02-13Shanghai United Imaging Healthcare Co.…uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo …PDF
K2540012026-01-13Spectrum Dynamics Medical, Ltd.VERITON CT 300 Series Digital SPECT/CT System (VERIT…PDF
K2538442025-12-30Mediso Medical Imaging Systems, Ltd.AnyScan 3.0 NM Scanner FamilyPDF
K2513702025-12-01Canon Medical Systems CorporationCartesion Prime (PCD-1000A/3) V10.21PDF
K2514012025-11-25Trustees of the University of Pennsylv…PennPET Explorer Positron Emission TomographPDF
K2524772025-09-09Hermes Medical Solutions ABHybrid Viewer (00859873006240)PDF
K2501702025-08-15Brightonix ImagingPHAROSPDF
K2515612025-07-31Siemens Medical Solutions USA, Inc.Biograph TrinionPDF
K2518392025-07-17Shanghai United Imaging Healthcare Co.…uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo …PDF
K2516712025-07-03Siemens Medical Solutions USA, Inc.Biograph Vision PET/CT Systems; Biograph mCT PET/CT …PDF
K2511532025-06-12Ge Medical Systems IsraelAuroraPDF
K2438812025-03-03Bracco Diagnostics, Inc.HeartSee™ Cardiac P.E.T. Processing Software For Myo…PDF
K2412662025-01-27Raysolution Healthcare Co., Ltd.Imaging system of positron emission and X-ray comput…PDF
K2436052025-01-17Ge Medical Systems Israel, Functional …AuroraPDF
K2435382024-12-12Shanghai United Imaging Healthcare Co.…uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo …PDF
K2413642024-11-08Hermes Medical Solutions ABHybrid Viewer (00859873006189)PDF
K2431862024-10-30Siemens Medical Solutions USA, Inc.Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X…PDF
K2415852024-08-30Shanghai United Imaging Healthcare Co.…uMI PanoramaPDF
K2415962024-08-15Shanghai United Imaging Healthcare Co.…uMI PanvivoPDF
K2416652024-08-08Ge Medical Systems Israel, Functional …Omni LegendPDF
K2418982024-07-26Siemens HealthineersSymbia SPECT and SPECT/CT SystemsPDF
K2417512024-07-15Positrigo AGNeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced…PDF
K2408272024-05-24Shimadzu Corporation Medical Systems D…SET-5002PDF
K2317622024-01-18Shanghai United Imaging Healthcare Co.…uEXPLORERPDF
K2336772024-01-12Siemens Medical Solutions USA, Inc.Biograph VK10PDF
K2327122023-10-03Shanghai United Imaging Healthcare Co.…uMI PanoramaPDF
K2325692023-09-21General Equipment For Medical Imaging,…CAREMIBRAINPDF
K2315762023-09-14Combinostics OYcNeuro cPETPDF
K2317482023-09-12Canon Medical Systems CorporationCartesion Prime (PCD-1000A/3) V10.15PDF

其中 30 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: KPS
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。