FDA Product Code
FDA Product Code KPS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1200
510(k) Clearances — 473 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261305 | MICSI-PET | Microstructure Imaging, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 | Traditional | PDF ↗ |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | 2026-05-21 | Special | PDF ↗ |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 | Traditional | PDF ↗ |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | 2026-01-13 | Special | PDF ↗ |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 | Traditional | PDF ↗ |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | 2025-12-01 | Traditional | PDF ↗ |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | 2025-11-25 | Traditional | PDF ↗ |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | 2025-09-09 | Special | PDF ↗ |
| K250170 | PHAROS | Brightonix Imaging | 2025-08-15 | Traditional | PDF ↗ |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | 2025-07-31 | Special | PDF ↗ |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 | Traditional | PDF ↗ |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2025-07-03 | Special | PDF ↗ |
| K251153 | Aurora | Ge Medical Systems Israel | 2025-06-12 | Traditional | PDF ↗ |
| K243881 | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 | Bracco Diagnostics, Inc. | 2025-03-03 | Traditional | PDF ↗ |
| K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | 2025-01-27 | Traditional | PDF ↗ |
| K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | 2025-01-17 | Traditional | PDF ↗ |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 | Special | PDF ↗ |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | 2024-11-08 | Traditional | PDF ↗ |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | Siemens Medical Solutions USA, Inc. | 2024-10-30 | Special | PDF ↗ |
| K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 | Traditional | PDF ↗ |
| K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 | Traditional | PDF ↗ |
| K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 | Traditional | PDF ↗ |
| K241898 | Symbia SPECT and SPECT/CT Systems | Siemens Healthineers | 2024-07-26 | Special | PDF ↗ |
| K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG | 2024-07-15 | Abbreviated | PDF ↗ |
| K240827 | SET-5002 | Shimadzu Corporation Medical Systems Division | 2024-05-24 | Abbreviated | PDF ↗ |
| K231762 | uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. | 2024-01-18 | Traditional | PDF ↗ |
| K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | 2024-01-12 | Traditional | PDF ↗ |
| K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 | Special | PDF ↗ |
| K232569 | CAREMIBRAIN | General Equipment For Medical Imaging, S.A. | 2023-09-21 | Traditional | PDF ↗ |
| K231576 | cNeuro cPET | Combinostics OY | 2023-09-14 | Traditional | PDF ↗ |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | 2023-09-12 | Traditional | PDF ↗ |
| K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 | Mcgovern Medical School | 2023-08-21 | Traditional | PDF ↗ |
| K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 | Traditional | PDF ↗ |
| K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | 2023-07-13 | Special | PDF ↗ |
| K231102 | Symbia Pro.specta VA20A Family | Siemens Medical Solutions USA, Inc. | 2023-05-17 | Special | PDF ↗ |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | 2023-04-28 | Abbreviated | PDF ↗ |
| K223212 | Precision DL | GE Healthcare | 2023-04-27 | Traditional | PDF ↗ |
| K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023-03-30 | Special | PDF ↗ |
| K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-03-10 | Traditional | PDF ↗ |
| K223547 | Biograph Vision Quadra PET/CT System | Siemens Medical Solutions USA, Inc. | 2022-12-22 | Special | PDF ↗ |
| K222895 | DynamicIQ | GE Medical Systems SCS | 2022-11-22 | Traditional | PDF ↗ |
| K221932 | Omni Legend | GE Healthcare | 2022-09-02 | Traditional | PDF ↗ |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 | Traditional | PDF ↗ |
| K214062 | Radialis PET Camera | Radialis, Inc. | 2022-02-04 | Traditional | PDF ↗ |
| K211964 | SubtlePET | Subtle Medical, Inc. | 2021-09-28 | Traditional | PDF ↗ |
| K212604 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021-09-16 | Special | PDF ↗ |
| K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | 2021-08-27 | Traditional | PDF ↗ |
| K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021-08-20 | Traditional | PDF ↗ |
| K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021-08-06 | Traditional | PDF ↗ |
| K211247 | PET VCAR | GE Medical Systems SCS | 2021-07-27 | Traditional | PDF ↗ |
| K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021-05-19 | Traditional | PDF ↗ |
| K210557 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021-05-12 | Traditional | PDF ↗ |
| K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-30 | Traditional | PDF ↗ |
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems Corporation | 2021-04-23 | Traditional | PDF ↗ |
| K202679 | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 | Mcgovern Medical School | 2021-04-12 | Traditional | PDF ↗ |
| K210418 | HYPER Focus | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-09 | Traditional | PDF ↗ |
| K210173 | StarGuide | GE Healthcare | 2021-03-29 | Traditional | PDF ↗ |
| K210450 | BBX-PET Scanner | Prescient Imaging, LLC | 2021-03-17 | Traditional | PDF ↗ |
| K210262 | Biograph Vision Quadra PET/CT System | Siemens Medical Solutions USA, Inc. | 2021-03-03 | Special | PDF ↗ |
| K202882 | Affinity | Hermes Medical Solutions AB | 2020-12-23 | Traditional | PDF ↗ |
| K202392 | SIR-Spheres Microspheres Activity Calculator (SMAC) | Sirtex Medical US Holdings, Inc. | 2020-10-23 | Traditional | PDF ↗ |
| K202349 | Cartesion Prime, PCD-1000A, V10.7 | Canon Medical Systems Corporation | 2020-10-15 | Traditional | PDF ↗ |
| K201807 | ANCORIS | Miegmbh | 2020-08-27 | Traditional | PDF ↗ |
| K201933 | ImagenSPECT 3.0 | Cardiovascular Imaging Technologies | 2020-08-11 | Special | PDF ↗ |
| K193210 | HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. | 2020-08-04 | Traditional | PDF ↗ |
| K200474 | Symbia 6.7 | Siemens Medical Solutions USA, Inc. | 2020-03-20 | Special | PDF ↗ |
| K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | Siemens Medical Solutions USA, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K192277 | CardIQ Flow | GE Medical Systems SCS | 2020-02-14 | Traditional | PDF ↗ |
| K193152 | Affinity | Hermes Medical Solutions AB | 2020-02-14 | Traditional | PDF ↗ |
| K193178 | Biograph Horizon | Siemens Medical Solution USA, Inc. | 2020-02-12 | Traditional | PDF ↗ |
| K193241 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | 2020-01-26 | Traditional | PDF ↗ |
| K191582 | Cartesion Prime | Canon Medical Systems Corporation | 2019-08-13 | Traditional | PDF ↗ |
| K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2019-07-12 | Traditional | PDF ↗ |
| K190900 | Biograph Vision | Siemens Medical Solutions USA, Inc. | 2019-05-06 | Special | PDF ↗ |
| K182938 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | 2018-12-18 | Traditional | PDF ↗ |
| K182336 | SubtlePET | Subtle Medical, Inc. | 2018-11-30 | Traditional | PDF ↗ |
| K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018-11-09 | Abbreviated | PDF ↗ |
| K181468 | Hybrid3D | Hermes Medical Solutions AB | 2018-10-25 | Traditional | PDF ↗ |
| K182237 | uMI 550 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-12 | Traditional | PDF ↗ |
| K180077 | NeuroQ 3.8 | Syntermed | 2018-08-16 | Traditional | PDF ↗ |
| K181343 | HeartSee Cardiac P.E.T. Processing Software | Bracco Diagnostics, Inc. | 2018-06-12 | Traditional | PDF ↗ |
| K180811 | Biograph Vision | Siemens Medical Solutions USA, Inc. | 2018-05-23 | Traditional | PDF ↗ |
| K180514 | VERITON NM | Spectrum Dynamics Medical, Ltd. | 2018-04-25 | Traditional | PDF ↗ |
| K173816 | NM/CT 850, NM/CT 860 | GE Healthcare | 2018-04-17 | Traditional | PDF ↗ |
| K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-13 | Traditional | PDF ↗ |
| K180318 | PET Digital Gating | Ge Medical Systems, LLC | 2018-04-11 | Traditional | PDF ↗ |
| K173547 | ImagenUniversal | Cardiovascular Imaging Technologies | 2018-01-12 | Traditional | PDF ↗ |
| K173578 | Biograph mCT Family of PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2017-12-20 | Special | PDF ↗ |
| K171719 | Hybrid3D | Hermes Medical Solutions AB | 2017-11-21 | Traditional | PDF ↗ |
| K171681 | Hermes Medical Imaging Suite v5.7 | Hermes Medical Solutions AB | 2017-11-21 | Traditional | PDF ↗ |
| K173023 | Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017-11-17 | Traditional | PDF ↗ |
| K172609 | CSMC Cardiac Suite | Cedars-Sinai Medical Center | 2017-11-03 | Special | PDF ↗ |
| K172406 | Ingenuity TF | Philips Medical Systems (Cleveland), Inc. | 2017-10-06 | Traditional | PDF ↗ |
| K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 | University of Texas Medical School AT Houston, Texas | 2017-09-22 | Traditional | PDF ↗ |
| K170904 | Biograph Horizon PET/CT | Siemens Medical Solutions USA, Inc. | 2017-06-01 | Special | PDF ↗ |
| K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017-06-01 | Traditional | PDF ↗ |
| K163394 | Hybrid3D | Hermes Medical Solutions AB | 2017-05-22 | Traditional | PDF ↗ |
| K162483 | Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. | 2017-01-09 | Traditional | PDF ↗ |
Product code KPS · Class II · Radiology. Data: openFDA.