Shanghai United Imaging Healthcare Co., Ltd. · Class II · Cleared Apr 3, 2026
| K-number | K260524 |
| Device name | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. |
| Product code | KPS |
| Device class | Class II |
| Decision date | Apr 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1200 |
The uMI Panvivo is a PET/CT imaging system that combines positron emission tomography with computed tomography to provide anatomical and functional images for detecting, diagnosing, staging, and monitoring abnormalities, lesions, tumors, inflammation, and infections across oncology, cardiology, neurology, and other clinical areas. The system can also be used for low-dose CT lung cancer screening and to aid in radiotherapy treatment planning.
The proposed uMI Panvivo LS features 360 detector rings with a 1069 mm axial field of view, compared to the predicate's models with 80–240 rings and 235–712 mm axial FOV. Key specifications are substantially identical: same scintillator material (LYSO), detector ring diameter (734 mm), spatial resolution (<3.5 mm at 1 cm), coincidence window (4.9 ns), and advanced functions (Deep MAC, Digital Gating, OncoFocus, NeuroFocus.Brain, uExcel DPR). The increased detector rings and axial FOV improve system sensitivity and scanning efficiency without changing fundamental operating principles.
ANSI/AAMI ES60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-44:2009, NEMA NU 2-2018, ISO 14971:2019, ISO 10993-1:2018, IEC 62304:2006, and 21 CFR 820 Quality System Regulation. Performance verification included phantom and clinical image testing per NEMA NU 2-2018 standards for PET performance metrics.
The proposed device employs identical basic operating principles, fundamental technologies, detector materials, spatial resolution specifications, and intended clinical use as the predicate device K253564. Differences in detector ring count and axial FOV represent enhancements in sensitivity and scanning range that do not affect safety or effectiveness. Performance testing demonstrates all design specifications are met, and clinical image evaluation by board-certified radiologists confirms image quality is sufficient for diagnostic use. No new safety or effectiveness concerns are raised.
View the full FDA submission: accessdata.fda.gov