Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPS — Predicate Candidate Screening
472 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
168 days90th percentile
472clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 | 89 | 0 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (113647 | Siemens Medical Solutions USA, Inc. | 2026-05-21 | 30 | 0 |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 | 45 | 0 |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 | 88 | 0 |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 31 | Spectrum Dynamics Medical, Ltd. | 2026-01-13 | 29 | 0 |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 | 28 | 0 |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | 2025-12-01 | 213 | 0 |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | 2025-11-25 | 203 | 0 |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | 2025-09-09 | 33 | 0 |
| K250170 | PHAROS | Brightonix Imaging | 2025-08-15 | 206 | 0 |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | 2025-07-31 | 71 | 0 |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 | 31 | 0 |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2025-07-03 | 34 | 0 |
| K251153 | Aurora | Ge Medical Systems Israel | 2025-06-12 | 59 | 0 |
| K243881 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial | Bracco Diagnostics, Inc. | 2025-03-03 | 75 | 0 |
| K241266 | Imaging system of positron emission and X-ray computed tomog | Raysolution Healthcare Co., Ltd. | 2025-01-27 | 266 | 0 |
| K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | 2025-01-17 | 57 | 0 |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 | 27 | 0 |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | 2024-11-08 | 178 | 0 |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364 | Siemens Medical Solutions USA, Inc. | 2024-10-30 | 30 | 0 |
| K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 | 88 | 0 |
| K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 | 73 | 0 |
| K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 | 59 | 1 |
| K241898 | Symbia SPECT and SPECT/CT Systems | Siemens Healthineers | 2024-07-26 | 28 | 0 |
| K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF | Positrigo AG | 2024-07-15 | 27 | 0 |
| K240827 | SET-5002 | Shimadzu Corporation Medical Systems Division | 2024-05-24 | 59 | 0 |
| K231762 | uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. | 2024-01-18 | 216 | 1 |
| K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | 2024-01-12 | 57 | 0 |
| K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 | 28 | 1 |
| K232569 | CAREMIBRAIN | General Equipment For Medical Imaging, S.A. | 2023-09-21 | 28 | 0 |
| K231576 | cNeuro cPET | Combinostics OY | 2023-09-14 | 106 | 0 |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | 2023-09-12 | 89 | 1 |
| K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Process | Mcgovern Medical School | 2023-08-21 | 69 | 0 |
| K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 | 56 | 0 |
| K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | 2023-07-13 | 21 | 0 |
| K231102 | Symbia Pro.specta VA20A Family | Siemens Medical Solutions USA, Inc. | 2023-05-17 | 29 | 0 |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 31 | Spectrum Dynamics Medical, Ltd. | 2023-04-28 | 56 | 0 |
| K223212 | Precision DL | GE Healthcare | 2023-04-27 | 192 | 0 |
| K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023-03-30 | 136 | 0 |
| K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | 2023-03-10 | 130 | 1 |
| K223547 | Biograph Vision Quadra PET/CT System | Siemens Medical Solutions USA, Inc. | 2022-12-22 | 27 | 0 |
| K222895 | DynamicIQ | GE Medical Systems SCS | 2022-11-22 | 60 | 0 |
| K221932 | Omni Legend | GE Healthcare | 2022-09-02 | 63 | 1 |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 | 186 | 0 |
| K214062 | Radialis PET Camera | Radialis, Inc. | 2022-02-04 | 39 | 0 |
| K211964 | SubtlePET | Subtle Medical, Inc. | 2021-09-28 | 96 | 0 |
| K212604 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | 2021-09-16 | 30 | 1 |
| K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | 2021-08-27 | 60 | 1 |
| K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021-08-20 | 66 | 0 |
| K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021-08-06 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda