uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co.,Ltd.The uMR Omega with uWS-MR-MRS is a magnetic resonance imaging (MRI) system combined with advanced software solutions designed for viewing, manipulating, and analyzing MR images. It includes features such as AI-assisted image reconstruction and multiple post-processing tools that aid clinicians in evaluating anatomical and functional information. This helps radiologists and physicians diagnose more effectively by providing enhanced image quality and quantitative assessment capabilities.
Intended Use
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) producing sagittal, transverse, coronal, and oblique cross-sectional and spectroscopic images to display anatomical structure and function of the head, body, and extremities. It supports diagnosis when interpreted by a trained physician, with optional contrast agent use depending on scan region.
Technology
The device is a 3.0T superconducting MRI system with a 75 cm bore and a comprehensive set of RF coils including new coils with increased element counts for better coverage. Software includes advanced pulse sequences, AI-assisted compressed sensing, deep learning image reconstruction (DeepRecon), image stitching, dynamic studies, fusion, spectroscopy, cardiac analysis, and other post-processing tools. The software runs as a stand-alone solution or integrated with UIH MRI scanners.
Performance
Performance testing included clinical evaluations in a diverse U.S. population with multiple imaging protocols and body parts, bench and software validation of advanced features such as DeepRecon AI reconstruction, spectroscopy sequences, cardiac mapping, and artifact reduction. The device met acceptance criteria for signal-to-noise ratio, uniformity, contrast, and structural measurements. Safety and biocompatibility testing were also conducted per relevant international standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/4/2022
8 months - 2
FDA Approval
10/27/2022
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