uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

The uMI Panvivo is a combined PET/CT imaging system that provides anatomical and functional images for diagnostic and therapeutic purposes. It is intended for assessing metabolic and physiologic functions in various body areas, supporting clinical applications in oncology, cardiology, neurology, and other specialties, and can aid in radiotherapy planning and lung cancer screening.

The proposed devices feature scalable PET detector rings (100, 80, 180, or 240 rings) with corresponding axial fields of view (295, 235, 534, or 712 mm) compared to the predicate's 100 and 80 rings. Newer models (ES and EX) have longer coincidence timing windows (4.9 ns vs. 4.6 ns) to accommodate more lines of response, and improved sensitivity and NECR peak values. Advanced features include NeuroFocus.Brain, uExcel DPR deep learning reconstruction, and Intelligent Assistant, which are new to the longer-axial models.

Conformance claimed to ANSI/AAMI ES60601-1, IEC 60601-1-2 and 60601-1-3, IEC 60601-2-44, NEMA NU 2-2018, IEC 62304 (software lifecycle), ISO 10993 (biocompatibility), ISO 14971 (risk management), and 21 CFR Part 820 (Quality System Regulation).

The proposed device employs the same basic operating principles, detector materials (LYSO), scintillator dimensions, and ring diameter as the predicate. Differences in detector ring count and axial FOV do not affect clinical effectiveness or safety—longer FOV reduces scanning time while maintained spatial resolution and image quality specifications demonstrate equivalence. New software features and algorithmic enhancements do not raise new safety or effectiveness concerns based on performance testing and radiologist review.