KPS
472 FDA 510(k) clearances · Product code
75 daysmedian time to decision
168 days90th percentile
472clearances measured
FDA profile
- Official device name
- System, Tomography, Computed, Emission
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1200
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2019: 105 · 2020: 22 · 2022: 15 · 2023: 22 · 2024: 23 · 2025: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| uMI Panvivo (uMI Panvivo M) (K261427) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 |
| Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (K261315) | Siemens Medical Solutions USA, Inc. | 2026-05-21 |
| uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K260524) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K253564) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 |
| VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (K254001) | Spectrum Dynamics Medical, Ltd. | 2026-01-13 |
| AnyScan 3.0 NM Scanner Family (K253844) | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 |
| Cartesion Prime (PCD-1000A/3) V10.21 (K251370) | Canon Medical Systems Corporation | 2025-12-01 |
| PennPET Explorer Positron Emission Tomograph (K251401) | Trustees of the University of Pennsylvania | 2025-11-25 |
| Hybrid Viewer (00859873006240) (K252477) | Hermes Medical Solutions AB | 2025-09-09 |
| PHAROS (K250170) | Brightonix Imaging | 2025-08-15 |
| Biograph Trinion (K251561) | Siemens Medical Solutions USA, Inc. | 2025-07-31 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K251839) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems (K251671) | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| Aurora (K251153) | Ge Medical Systems Israel | 2025-06-12 |
| HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (K243881) | Bracco Diagnostics, Inc. | 2025-03-03 |
| Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (K241266) | Raysolution Healthcare Co., Ltd. | 2025-01-27 |
| Aurora (K243605) | Ge Medical Systems Israel, Functional Imaging | 2025-01-17 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K243538) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 |
| Hybrid Viewer (00859873006189) (K241364) | Hermes Medical Solutions AB | 2024-11-08 |
| Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family (K243186) | Siemens Medical Solutions USA, Inc. | 2024-10-30 |
| uMI Panorama (K241585) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 |
| uMI Panvivo (K241596) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 |
| Omni Legend (K241665) | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 |
| Symbia SPECT and SPECT/CT Systems (K241898) | Siemens Healthineers | 2024-07-26 |
| NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat (K241751) | Positrigo AG | 2024-07-15 |
| SET-5002 (K240827) | Shimadzu Corporation Medical Systems Division | 2024-05-24 |
| uEXPLORER (K231762) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-01-18 |
| Biograph VK10 (K233677) | Siemens Medical Solutions USA, Inc. | 2024-01-12 |
| uMI Panorama (K232712) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 |
| CAREMIBRAIN (K232569) | General Equipment For Medical Imaging, S.A. | 2023-09-21 |
| cNeuro cPET (K231576) | Combinostics OY | 2023-09-14 |
| Cartesion Prime (PCD-1000A/3) V10.15 (K231748) | Canon Medical Systems Corporation | 2023-09-12 |
| Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731) | Mcgovern Medical School | 2023-08-21 |
| uMI Panorama (K231572) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 |
| Biograph Vision.X and Biograph Vision.X Edge (K231833) | Siemens Medical Solutions USA, Inc. | 2023-07-13 |
| Symbia Pro.specta VA20A Family (K231102) | Siemens Medical Solutions USA, Inc. | 2023-05-17 |
| VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (K230600) | Spectrum Dynamics Medical, Ltd. | 2023-04-28 |
| Precision DL (K223212) | GE Healthcare | 2023-04-27 |
| Emory Cardiac Toolbox 4.3 (K223422) | Syntermed | 2023-03-30 |
| uMI Panorama (K223325) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-03-10 |
| Biograph Vision Quadra PET/CT System (K223547) | Siemens Medical Solutions USA, Inc. | 2022-12-22 |
| DynamicIQ (K222895) | GE Medical Systems SCS | 2022-11-22 |
| Omni Legend (K221932) | GE Healthcare | 2022-09-02 |
| EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows (K213731) | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 |
| Radialis PET Camera (K214062) | Radialis, Inc. | 2022-02-04 |
| SubtlePET (K211964) | Subtle Medical, Inc. | 2021-09-28 |
| Symbia VA10A Family (K212604) | Siemens Medical Solutions USA, Inc. | 2021-09-16 |
| MyoSPECT, MyoSpect ES (K212004) | GE Healthcare | 2021-08-27 |
| Discovery MI Gen2 (K211846) | Ge Medical Systems, LLC | 2021-08-20 |
| Vereos PET/CT (K211764) | Philips Medical Systems Nederland B.V. | 2021-08-06 |
| PET VCAR (K211247) | GE Medical Systems SCS | 2021-07-27 |
| Vereos PET/CT (K210880) | Philips Medical Systems Nederland B.V. | 2021-05-19 |
| Symbia VA10A Family (K210557) | Siemens Medical Solutions USA, Inc. | 2021-05-12 |
| HYPER AiR (K210001) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-30 |
| Cartesion Prime (PCD-1000A/3) V10.8 (K203314) | Canon Medical Systems Corporation | 2021-04-23 |
| Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (K202679) | Mcgovern Medical School | 2021-04-12 |
| HYPER Focus (K210418) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-09 |
| StarGuide (K210173) | GE Healthcare | 2021-03-29 |
| BBX-PET Scanner (K210450) | Prescient Imaging, LLC | 2021-03-17 |
| Biograph Vision Quadra PET/CT System (K210262) | Siemens Medical Solutions USA, Inc. | 2021-03-03 |
| Affinity (K202882) | Hermes Medical Solutions AB | 2020-12-23 |
| SIR-Spheres Microspheres Activity Calculator (SMAC) (K202392) | Sirtex Medical US Holdings, Inc. | 2020-10-23 |
| Cartesion Prime, PCD-1000A, V10.7 (K202349) | Canon Medical Systems Corporation | 2020-10-15 |
| ANCORIS (K201807) | Miegmbh | 2020-08-27 |
| ImagenSPECT 3.0 (K201933) | Cardiovascular Imaging Technologies | 2020-08-11 |
| HYPER DLR (K193210) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-08-04 |
| Symbia 6.7 (K200474) | Siemens Medical Solutions USA, Inc. | 2020-03-20 |
| Affinity (K193152) | Hermes Medical Solutions AB | 2020-02-14 |
| Biograph Vision, Biograph mCT Family of PET/CTs (K193248) | Siemens Medical Solutions USA, Inc. | 2020-02-14 |
| CardIQ Flow (K192277) | GE Medical Systems SCS | 2020-02-14 |
| Biograph Horizon (K193178) | Siemens Medical Solution USA, Inc. | 2020-02-12 |
| Emission Computed Tomography System (K193241) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-01-26 |
| Cartesion Prime (K191582) | Canon Medical Systems Corporation | 2019-08-13 |
| VERITON CT whole body SPECT/CT system (K190457) | Spectrum Dynamics Medical, Ltd. | 2019-07-12 |
| Biograph Vision (K190900) | Siemens Medical Solutions USA, Inc. | 2019-05-06 |
| Emission Computed Tomography System (K182938) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-12-18 |
| SubtlePET (K182336) | Subtle Medical, Inc. | 2018-11-30 |
| VERITON CT whole body SPECT/CT system (K182484) | Spectrum Dynamics Medical, Ltd. | 2018-11-09 |
| Hybrid3D (K181468) | Hermes Medical Solutions AB | 2018-10-25 |
| uMI 550 PET/CT System (K182237) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-12 |
| NeuroQ 3.8 (K180077) | Syntermed | 2018-08-16 |
| HeartSee Cardiac P.E.T. Processing Software (K181343) | Bracco Diagnostics, Inc. | 2018-06-12 |
| Biograph Vision (K180811) | Siemens Medical Solutions USA, Inc. | 2018-05-23 |
| VERITON NM (K180514) | Spectrum Dynamics Medical, Ltd. | 2018-04-25 |
| NM/CT 850, NM/CT 860 (K173816) | GE Healthcare | 2018-04-17 |
| uMI 780 PET/CT System (K172143) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-13 |
| PET Digital Gating (K180318) | Ge Medical Systems, LLC | 2018-04-11 |
| ImagenUniversal (K173547) | Cardiovascular Imaging Technologies | 2018-01-12 |
| Biograph mCT Family of PET/CT Systems (K173578) | Siemens Medical Solutions USA, Inc. | 2017-12-20 |
| Hermes Medical Imaging Suite v5.7 (K171681) | Hermes Medical Solutions AB | 2017-11-21 |
| Hybrid3D (K171719) | Hermes Medical Solutions AB | 2017-11-21 |
| Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold (K173023) | Siemens Medical Solutions USA, Inc. | 2017-11-17 |
| CSMC Cardiac Suite (K172609) | Cedars-Sinai Medical Center | 2017-11-03 |
| Ingenuity TF (K172406) | Philips Medical Systems (Cleveland), Inc. | 2017-10-06 |
| Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (K171303) | University of Texas Medical School AT Houston, Texas | 2017-09-22 |
| Biograph Horizon PET/CT (K170904) | Siemens Medical Solutions USA, Inc. | 2017-06-01 |
| Celesteion, PCA-9000A/3 (K170490) | Toshibamedical Systems Corporation | 2017-06-01 |
| Hybrid3D (K163394) | Hermes Medical Solutions AB | 2017-05-22 |
| Symbia Intevo Bold (K162483) | Siemens Medical Solutions USA, Inc. | 2017-01-09 |
| D-SPECT Scanner, D-SPECT L Scanner (K161740) | Spectrum Dynamics Medical, Ltd. | 2016-11-04 |
Track KPS automatically
Every clearance here is in the API, with alerts when new ones post.