MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.The MAGNETOM Vida with syngo MR XA50A is an MRI system that produces detailed cross-sectional images and spectra of the head, body, or extremities to assist clinicians in diagnosis. It incorporates advanced AI-based image reconstruction algorithms such as Deep Resolve Swift Brain and Deep Resolve Boost to enable faster and higher-quality MRI scans, improving diagnostic workflows and patient outcomes.
Intended Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, displaying internal structure and/or function of the head, body, or extremities. Contrast agents may be used depending on the region of interest. It can also be used during interventional procedures with MR compatible devices.
Technology
The device includes new and modified software featuring AI-based image reconstruction methods such as Deep Resolve Swift Brain for fast brain imaging, Deep Resolve Boost for 2D TSE data reconstruction, and BLADE diffusion imaging with reduced sensitivity to artifacts. It incorporates multi-shot EPI pulse sequences and deep learning algorithms to enhance image quality and speed. It features software updates including motion correction and assisted angiography planning.
Performance
Performance testing involved evaluation of new and modified software features using sample clinical images for image quality assessment and software verification/validation according to FDA guidance. Testing demonstrated that the device performs as intended and is substantially equivalent to the predicate device. No new clinical trials were conducted, but clinical publications supporting AI reconstruction methods were referenced.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2021
3 months - 2
FDA Approval
2/25/2022
Other devices from Siemens Medical Solutions USA, Inc.
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