KPS
- 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)
- 472 件
该代码近三年的 510(k)（32 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261427 | 2026-07-28 | Shanghai United Imaging Healthcare Co. | uMI Panvivo (uMI Panvivo M) 摘要 |
| K261315 | 2026-05-21 | Siemens Medical Solutions USA, Inc. | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 摘要 |
| K260524 | 2026-04-03 | Shanghai United Imaging Healthcare Co. | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvi 摘要 |
| K253564 | 2026-02-13 | Shanghai United Imaging Healthcare Co. | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo 摘要 |
| K254001 | 2026-01-13 | Spectrum Dynamics Medical, Ltd. | VERITON CT 300 Series Digital SPECT/CT System (VERIT 摘要 |
| K253844 | 2025-12-30 | Mediso Medical Imaging Systems, Ltd. | AnyScan 3.0 NM Scanner Family 摘要 |
| K251370 | 2025-12-01 | Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.21 摘要 |
| K251401 | 2025-11-25 | Trustees of the University of Pennsylv | PennPET Explorer Positron Emission Tomograph 摘要 |
| K252477 | 2025-09-09 | Hermes Medical Solutions AB | Hybrid Viewer (00859873006240) 摘要 |
| K250170 | 2025-08-15 | Brightonix Imaging | PHAROS 摘要 |
| K251561 | 2025-07-31 | Siemens Medical Solutions USA, Inc. | Biograph Trinion 摘要 |
| K251839 | 2025-07-17 | Shanghai United Imaging Healthcare Co. | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo 摘要 |
| K251671 | 2025-07-03 | Siemens Medical Solutions USA, Inc. | Biograph Vision PET/CT Systems; Biograph mCT PET/CT 摘要 |
| K251153 | 2025-06-12 | Ge Medical Systems Israel | Aurora 摘要 |
| K243881 | 2025-03-03 | Bracco Diagnostics, Inc. | HeartSee Cardiac P.E.T. Processing Software For Myo 摘要 |
| K241266 | 2025-01-27 | Raysolution Healthcare Co., Ltd. | Imaging system of positron emission and X-ray comput 摘要 |
| K243605 | 2025-01-17 | Ge Medical Systems Israel, Functional | Aurora 摘要 |
| K243538 | 2024-12-12 | Shanghai United Imaging Healthcare Co. | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo 摘要 |
| K241364 | 2024-11-08 | Hermes Medical Solutions AB | Hybrid Viewer (00859873006189) 摘要 |
| K243186 | 2024-10-30 | Siemens Medical Solutions USA, Inc. | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X 摘要 |
| K241585 | 2024-08-30 | Shanghai United Imaging Healthcare Co. | uMI Panorama 摘要 |
| K241596 | 2024-08-15 | Shanghai United Imaging Healthcare Co. | uMI Panvivo 摘要 |
| K241665 | 2024-08-08 | Ge Medical Systems Israel, Functional | Omni Legend 摘要 |
| K241898 | 2024-07-26 | Siemens Healthineers | Symbia SPECT and SPECT/CT Systems 摘要 |
| K241751 | 2024-07-15 | Positrigo AG | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced 摘要 |
| K240827 | 2024-05-24 | Shimadzu Corporation Medical Systems D | SET-5002 摘要 |
| K231762 | 2024-01-18 | Shanghai United Imaging Healthcare Co. | uEXPLORER 摘要 |
| K233677 | 2024-01-12 | Siemens Medical Solutions USA, Inc. | Biograph VK10 摘要 |
| K232712 | 2023-10-03 | Shanghai United Imaging Healthcare Co. | uMI Panorama 摘要 |
| K232569 | 2023-09-21 | General Equipment For Medical Imaging, | CAREMIBRAIN 摘要 |
| K231576 | 2023-09-14 | Combinostics OY | cNeuro cPET 摘要 |
| K231748 | 2023-09-12 | Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.15 摘要 |
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。