AI devices with FDA product code KPS — System, Tomography, Computed, Emission
Product code KPS (“System, Tomography, Computed, Emission” in openFDA) covers 26 devices on the FDA AI-enabled list, from 13 companies. Most are reviewed by the Radiology panel (26). The most recent decision was uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) on April 3, 2026.
26AI devices
12Companies
2018First decision
2026-04-03Latest decision
Trend: devices per year
2018202020212023202420252026
Top companies
All 26 devices, newest first
- 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. · Radiology
- 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. · Radiology
- 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. · Radiology
- Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems Corporation · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- AuroraGE Medical Systems Israel · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co.,Ltd. · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- uMI PanvivoShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Omni LegendGE Medical Systems Israel, Functional Imaging · Radiology
- Biograph VK10Siemens Medical Solutions USA, Inc. · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Cartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems Corporation · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc. · Radiology
- Precision DLGE Healthcare · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- SubtlePETSubtle Medical, Inc. · Radiology
- Discovery MI Gen2GE Medical Systems, LLC. · Radiology
- Vereos PET/CTPhilips Medical Systems Nederland B.V. · Radiology
- HYPER AiRShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- Cartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems Corporation · Radiology
- HYPER DLRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc · Radiology
- Biograph HorizonSiemens Medical Solution USA, Inc. · Radiology
- SubtlePETSubtle Medical, Inc. · Radiology