uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.The uMI Panorama is a diagnostic imaging system combining PET and CT scans to provide both functional and anatomical information of the body. It helps healthcare professionals detect and evaluate diseases in oncology, cardiology, and neurology by offering fused metabolic and anatomical images. The device includes AI-based software updates to improve image reconstruction and analysis, enhancing diagnostic accuracy and patient management.
Intended Use
A diagnostic imaging system combining PET and CT modalities to assist in detection, diagnosis, staging, treatment planning and response evaluation for diseases, inflammation, infection and disorders including oncology, cardiology and neurology.
Technology
The device integrates a PET system with LYSO scintillator detectors for high axial field of view (280 mm or 350 mm) and a 160-slice CT. It includes software updates: uExcel Focus (deep learning based motion correction and image enhancement) and uKinetics (generation of direct and indirect parametric images). It maintains CT single modality functionality and uses standard medical device safety and software standards.
Performance
Performance testing included bench testing for dosimetry and image quality confirming equivalence to predicate device. Clinical image evaluation by board-certified nuclear medicine physicians showed improved image quality and diagnostic sufficiency with uExcel Focus deep learning correction, and bench tests showed uKinetics provided quantitatively accurate parametric images.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/5/2023
28 days - 2
FDA Approval
10/3/2023
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.