uMR Jupiter
Shanghai United Imaging Healthcare Co., LtduMR Jupiter is a 5 Tesla superconducting MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It generates detailed anatomical and functional images of the head, body, and extremities to assist clinical diagnosis. The device features advanced AI-accelerated image reconstruction technology, enhancing image quality and scan speed, supporting clinicians in making accurate and timely diagnoses.
Intended Use
uMR Jupiter 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. The device is intended for patients > 20 kg/44 lbs.
Technology
uMR Jupiter is a 5T superconducting MRI system with a 60cm bore and 8 channel RF transmit system. It includes components such as magnet, RF power amplifier, RF coils, gradient coils, patient table, and computer, designed according to NEMA and DICOM standards. It utilizes AI-accelerated compressed sensing (ACS) for image reconstruction, trained on diverse anatomical datasets to enhance image quality and accelerate scan times.
Performance
Performance testing included non-clinical image performance validation, conformance to multiple international electrical safety, electromagnetic compatibility, and MRI-specific standards. Clinical image quality was reviewed by board-certified radiologists confirming diagnostic image quality. The AI reconstruction algorithm (ACS) was tested on diverse demographic datasets and showed improved SNR and resolution compared to conventional compressed sensing, with phantom tests and clinical image comparisons verifying safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/16/2023
5 months - 2
FDA Approval
4/26/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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