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

The uMI Panvivo is a PET/CT imaging system that combines a 295/235 mm axial field-of-view PET scanner with a 160-slice CT system to provide anatomical and functional images. It is designed for detecting, evaluating, diagnosing, staging, and monitoring abnormalities, lesions, tumors, inflammation, and diseases across multiple clinical areas including oncology, cardiology, neurology, and infection/inflammation, and can support radiotherapy planning and interventional procedures.

The proposed device maintains identical hardware specifications to the predicate (same PET scintillator material LYSO, detector ring configurations, patient bore size, and uCT 780 CT system). The key differences are the addition of seven software-based image processing features: Deep MAC (metal artifact correction), Digital Gating (respiratory motion signal extraction), OncoFocus (respiratory motion correction), NeuroFocus (head motion correction), DeepRecon.PET (deep learning noise reduction), uExcel DPR (AI-enhanced PET reconstruction), and uKinetics (kinetic modeling toolkit).

Standards cited include ANSI/AAMI ES60601-1:2005, IEC 60601 series (parts 1-2, 1-3, 1-6, 2-44), IEC 60825-1, IEC 62304, NEMA NU 2-2018, NEMA PS 3.1-3.20 (DICOM), ISO 10993 series (biocompatibility), ISO 14971 (risk management), and FDA guidance on software in medical devices and cybersecurity management.

The proposed device has identical hardware architecture, PET/CT configuration, and intended use as the predicate (K243538). The software additions are image post-processing algorithms based on deep learning that improve image quality metrics (noise reduction, contrast enhancement, motion artifact correction, metal artifact correction) without altering the fundamental diagnostic function. Validation testing on diverse patient populations demonstrated that all new features achieve intended performance (improved SNR, CNR, lesion volume accuracy, metal artifact reduction) while preserving quantitative accuracy and receiving board-certified radiologist approval, confirming they do not raise new safety or effectiveness concerns.