The uMR 680 is a 1.5T superconducting magnetic resonance imaging device that produces detailed anatomical and functional images to assist physicians in diagnosis. It includes components such as magnets, RF coils, and software for imaging the head, body, and extremities, helping clinicians with diagnostic imaging using MRI technology.
Intended Use
The uMR 680 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 from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
Technology
The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm patient bore, consisting of magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module. Designed to conform to NEMA and DICOM standards. Modifications include addition of Breast Coil-24 and Magnetic Resonance Elastography (MRE).
Performance
Testing was conducted including surface heating, electrical/mechanical safety, SNR and uniformity, biocompatibility, EMC, clinical image quality assessments for the Breast Coil-24 and MRE features. Tests confirmed that image quality is sufficient for diagnostic use and all safety and performance criteria were met, supporting substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2024
23 days - 2
FDA Approval
4/10/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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