Device type
System, Tomography, Computed, Emission
Product code KPS · Class II · 21 CFR 892.1200 · Radiology
Recent 510(k)s
Recent recalls
Oct 7, 2026
Z-3287-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3284-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3286-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3285-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3283-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3288-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing