The uMR 780 is a 3.0 Tesla MRI system designed to generate high-quality cross-sectional and spectroscopic images of the head, body, and extremities. It assists clinicians in diagnosing various conditions by providing detailed anatomical and functional images, with the option to use contrast agents. The latest version includes software enhancements such as new pulse sequences and AI-assisted image reconstruction methods, improving image quality and analysis.
Intended Use
The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived when interpreted by a trained physician may assist diagnosis. Contrast agents may be used depending on region of interest.
Technology
The updated uMR 780 has the same hardware configuration as the predicate. It includes new or modified pulse sequences and imaging processing software options such as FACT, PSIR, computed DWI, inline T1/T2* maps, SWI+, and AI-assisted compressed sensing reconstruction. It employs the same fundamental MRI scientific technology as the predicate device.
Performance
Performance evaluation included spectroscopy, computed DWI, and AI-assisted compressed sensing demonstrating the device performs as expected and is substantially equivalent to predicate devices. No clinical testing was conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2019
5 months - 2
FDA Approval
5/5/2020
Other devices from Shanghai United Imaging Healthcare Co., Ltd
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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