The uMR Omega is a 3.0 Tesla superconducting MRI system designed for producing high-quality cross-sectional images and spectroscopic images of the head, body, and extremities. It helps clinicians diagnose by providing detailed anatomical and functional images that can be interpreted by trained physicians. This device is designed to meet industry imaging standards and includes advanced components such as RF coils and gradient amplifiers to ensure high image quality.
Intended Use
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device producing sagittal, transverse, coronal, and oblique cross-sectional and spectroscopic images displaying internal anatomical structure and/or function of the head, body, and extremities. Images and derived parameters can assist diagnosis.
Technology
uMR Omega is a 3.0T superconducting MRI system featuring a 75cm patient bore, magnet, RF coils, gradient coils and amplifiers, spectrometer, and computer. Designed to comply with NEMA and DICOM standards, it produces high-quality diagnostic images via advanced hardware and software systems.
Performance
Performance testing includes conformity with NEMA standards for image quality and surface heating, ANSI/AAMI electrical/mechanical safety standards, IEC standards for EMC immunity and electrostatic discharge, biocompatibility evaluations, and clinical image quality approval by a board-certified radiologist. All tests were passed, demonstrating the device performs as expected with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/26/2024
25 days - 2
FDA Approval
3/22/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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