KPS
- Product code
- KPS
- Device name
- System, Tomography, Computed, Emission
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1200
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 32
- Summaries archived here
- 30 (direct download)
- 510(k) clearances (all years, FDA)
- 472 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (32)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261427 | 2026-07-28 | Shanghai United Imaging Healthcare Co.… | uMI Panvivo (uMI Panvivo M) | |
| K261315 | 2026-05-21 | Siemens Medical Solutions USA, Inc. | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3… | FDA |
| K260524 | 2026-04-03 | Shanghai United Imaging Healthcare Co.… | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvi… | FDA |
| K253564 | 2026-02-13 | Shanghai United Imaging Healthcare Co.… | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo … | |
| K254001 | 2026-01-13 | Spectrum Dynamics Medical, Ltd. | VERITON CT 300 Series Digital SPECT/CT System (VERIT… | |
| K253844 | 2025-12-30 | Mediso Medical Imaging Systems, Ltd. | AnyScan 3.0 NM Scanner Family | |
| K251370 | 2025-12-01 | Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.21 | |
| K251401 | 2025-11-25 | Trustees of the University of Pennsylv… | PennPET Explorer Positron Emission Tomograph | |
| K252477 | 2025-09-09 | Hermes Medical Solutions AB | Hybrid Viewer (00859873006240) | |
| K250170 | 2025-08-15 | Brightonix Imaging | PHAROS | |
| K251561 | 2025-07-31 | Siemens Medical Solutions USA, Inc. | Biograph Trinion | |
| K251839 | 2025-07-17 | Shanghai United Imaging Healthcare Co.… | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo … | |
| K251671 | 2025-07-03 | Siemens Medical Solutions USA, Inc. | Biograph Vision PET/CT Systems; Biograph mCT PET/CT … | |
| K251153 | 2025-06-12 | Ge Medical Systems Israel | Aurora | |
| K243881 | 2025-03-03 | Bracco Diagnostics, Inc. | HeartSee Cardiac P.E.T. Processing Software For Myo… | |
| K241266 | 2025-01-27 | Raysolution Healthcare Co., Ltd. | Imaging system of positron emission and X-ray comput… | |
| K243605 | 2025-01-17 | Ge Medical Systems Israel, Functional … | Aurora | |
| K243538 | 2024-12-12 | Shanghai United Imaging Healthcare Co.… | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo … | |
| K241364 | 2024-11-08 | Hermes Medical Solutions AB | Hybrid Viewer (00859873006189) | |
| K243186 | 2024-10-30 | Siemens Medical Solutions USA, Inc. | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X… | |
| K241585 | 2024-08-30 | Shanghai United Imaging Healthcare Co.… | uMI Panorama | |
| K241596 | 2024-08-15 | Shanghai United Imaging Healthcare Co.… | uMI Panvivo | |
| K241665 | 2024-08-08 | Ge Medical Systems Israel, Functional … | Omni Legend | |
| K241898 | 2024-07-26 | Siemens Healthineers | Symbia SPECT and SPECT/CT Systems | |
| K241751 | 2024-07-15 | Positrigo AG | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced… | |
| K240827 | 2024-05-24 | Shimadzu Corporation Medical Systems D… | SET-5002 | |
| K231762 | 2024-01-18 | Shanghai United Imaging Healthcare Co.… | uEXPLORER | |
| K233677 | 2024-01-12 | Siemens Medical Solutions USA, Inc. | Biograph VK10 | |
| K232712 | 2023-10-03 | Shanghai United Imaging Healthcare Co.… | uMI Panorama | |
| K232569 | 2023-09-21 | General Equipment For Medical Imaging,… | CAREMIBRAIN | |
| K231576 | 2023-09-14 | Combinostics OY | cNeuro cPET | |
| K231748 | 2023-09-12 | Canon Medical Systems Corporation | Cartesion Prime (PCD-1000A/3) V10.15 |
Official FDA classification page: KPS
Classification and pathway per current FDA publications. Data from openFDA (CC0).