Intended Use

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.

Technology

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

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/29/2023

    4 months
  • 2

    FDA Approval

    5/24/2024

Other devices from Shanghai United Imaging Healthcare Co., Ltd.

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