uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

The uMI Panvivo is a PET/CT imaging system that combines a 235/295 mm axial field-of-view PET scanner with a 160-slice CT system to provide anatomical and functional images. It is intended for assessing metabolic and physiologic functions across the body and can aid in detection, diagnosis, staging, and monitoring of abnormalities, tumors, inflammation, and infections in oncology, neurology, and other clinical areas, as well as low-dose lung cancer screening.

The proposed device introduces a new uMI Panvivo S model with 80 PET detector rings and 235 mm axial FOV, compared to the predicate's 100 PET rings and 295 mm axial FOV. Both use LYSO scintillator material, the same uCT 780 CT system, 700 mm patient bore, and 250 kg maximum table load. The reduction in detector rings and axial FOV represents a scaled-down configuration of the same fundamental PET/CT architecture.

Conformance to ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, IEC 60825-1, IEC 60601-1-6, IEC 62304, NEMA NU 2-2018, IEC TR 60601-4-2, NEMA PS 3.1-3.20 (DICOM), ISO 10993-1/5/10, ISO 14971, and FDA guidance on software and cybersecurity in medical devices.

The proposed device employs identical basic operating principles, fundamental technologies, and indications for use as the predicate device. The only difference is a scaled reduction in PET detector rings (80 vs. 100) and axial FOV (235 vs. 295 mm), which does not introduce new safety or effectiveness concerns. Sample clinical images reviewed by a U.S. board-certified radiologist confirmed diagnostic image quality, and non-clinical testing verified design specification compliance, supporting substantial equivalence.