uWS-MR is a comprehensive medical imaging software that assists clinicians in viewing, manipulating, and analyzing MR images. It supports numerous advanced applications such as MR cardiac analysis, neuroimaging evaluation, spectroscopy, dynamic imaging, vessel analysis, and fusion of image series. It facilitates better interpretation and quantitative evaluation of various MR studies to aid diagnostic and clinical decision-making.
Intended Use
Software solution intended for viewing, manipulation, communication, and storage of MR medical images, supporting interpretation and evaluation within healthcare institutions. Includes advanced applications for stitching, dynamic studies, image fusion, spectroscopy, breast evaluation, brain perfusion, vessel analysis, neurological and cardiac MRI analysis.
Technology
uWS-MR operates as stand-alone software or as a post-processing option for cleared UIH MR scanners, transferring images via DICOM 3.0 or external media. It supports various functional and anatomical MR datasets at different time points and frames, with multiple display formats (MIP, volume rendering) and statistical analyses of grayscale values. Advanced applications include virtual camera views, parameter mapping, and quantitative evaluation tools for cardiac and neurological MR images.
Performance
Software verification and validation testing demonstrated safety and efficacy, with hazard analysis and moderate level of concern classification. No animal or clinical studies were required. Performance evaluation report provided for MR Cardiac Analysis. Compliance with standards such as DICOM, ISO 14971, IEC 62304 was documented.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/20/2019
8 months - 2
FDA Approval
6/1/2020
Other devices from Shanghai United Imaging Healthcare Co., Ltd
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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