The uPMR 790 by Shanghai United Imaging Healthcare Co., Ltd. is a combined PET and MRI system that simultaneously captures high-resolution metabolic and anatomical images of the body to assist clinicians in diagnosis. It includes advanced AI-based image reconstruction and processing techniques, like DeepRecon for denoising and ACS for accelerated image reconstruction, improving image quality and scan efficiency without radiation exposure from MRI. This helps healthcare providers better assess physiological and anatomical conditions in patients.
The uPMR 790 system combines magnetic resonance diagnostic devices and positron emission tomography scanners providing registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically, to assist healthcare providers in assessing metabolic and physiological functions.
The uPMR 790 integrates PET detectors into a 3.0T MR scanner for simultaneous acquisition. It supports Time of Flight (ToF) for PET, includes various RF coils, pulse sequences, MR and PET image processing methods, and AI-based reconstruction algorithms such as DeepRecon and AI-assisted Compressed Sensing (ACS). It follows NEMA and DICOM standards and maintains independent MR and PET functionality.
Performance was verified through non-clinical testing including image quality, safety, and software validation against predicate devices. AI algorithms DeepRecon and ACS were trained and tested on independent datasets and demonstrated equivalent or superior image quality compared to predicate methods. Clinical image quality was confirmed by board-certified radiologists.
No predicate devices specified
Submission
12/29/2023
FDA Approval
5/24/2024
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