The uMR 680 is a 1.5 Tesla superconducting magnetic resonance imaging (MRI) system designed to produce diagnostic-quality images of the head, body, and extremities. It includes a deep-learning based image processing algorithm called DeepRecon for image denoising and super-resolution, enhancing image quality and assisting clinicians in diagnosis.
Intended Use
The uMR 680 system is indicated for use as a magnetic resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images and spectroscopic images to display internal anatomical structure and/or function of the head, body, and extremities. Contrast agents may be used depending on the region of interest. These images and derived physical parameters, when interpreted by a trained physician, may assist diagnosis.
Technology
The device is a 1.5T superconducting MRI system with 70cm bore size, consisting of a magnet, RF coils, gradient coils, gradient and RF power amplifiers, patient table, spectrometer, computer and software. It supports multiple coils and advanced application software features including image correction and advanced imaging sequences. The key technological aspect is the DeepRecon deep learning algorithm for image denoising and super-resolution reconstruction, trained on large datasets from multiple body parts.
Performance
Performance testing included electrical safety, electromagnetic compatibility, image quality, biological safety, acoustic noise, and SAR characterization per international standards. Clinical images demonstrated diagnostic quality. DeepRecon was clinically validated on 68 US subjects with diverse demographics. Image quality metrics showed significant improvement in SNR, uniformity, resolution, contrast, and structural measurement accuracy compared to non-DeepRecon images. Radiologist evaluations confirmed diagnostic equivalence or superiority.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/12/2022
5 months - 2
FDA Approval
2/16/2023
Other devices from Shanghai United Imaging Intelligence Co., Ltd.
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