The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.
Intended Use
The uMR Omega 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.
Technology
The uMR Omega is a 3.0T superconducting MRI device with a 75 cm bore, including components such as magnet, RF coils, gradient coils, spectrometer, and imaging processing algorithms. It conforms to NEMA and DICOM standards and supports newly added RF coils, pulse sequences, and image reconstruction methods. SparkCo uses AI to detect and correct spark artifacts to improve image quality.
Performance
Performance testing included non-clinical tests for image quality, safety, and surface heating, as well as clinical image reviews by radiologists demonstrating diagnostic quality. The SparkCo AI algorithm was tested and showed 94% spark detection accuracy and improved image quality. The Inline ECV segmentation algorithm showed 100% satisfaction in various subgroups. All tests support safety and effectiveness equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
7 months - 2
FDA Approval
5/21/2025
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uMR Jupiter2025 • 510K
- uMR Ultra2025 • 510K
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2025 • 510K
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