MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA Inc.The MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A are advanced MRI diagnostic systems that produce detailed cross-sectional images and spectra of the head, body, or extremities. The device uses sophisticated MRI pulse sequences and integrates deep learning-based reconstruction algorithms to produce high-quality images quickly and reliably, aiding physicians in diagnosis and in planning interventional procedures.
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, and that displays the internal structure and/or function of the head, body, or extremities. It may be used for imaging during interventional procedures with compatible devices and usable contrast agents.
Technology
The device consists of hardware and software features, including new software syngo MR XA50A and transferred hardware such as the Nexaris Dockable Table, Head Frame, Nexaris Spine 36 coil, and Beat Sensor for cardiac triggers. Software features include advanced pulse sequences (e.g., SVS_EDIT, BEAT_FQ_nav, GRE_WAVE), deep learning-based reconstruction algorithms (Deep Resolve Swift Brain, Deep Resolve Boost), motion correction methods, and workflow assists for prostate and peripheral angiography imaging.
Performance
Performance testing involved verification and validation of transferred hardware and software features, demonstrating that the devices perform as intended and are substantially equivalent to predicate devices. No additional clinical tests were performed. Risk management and compliance with international standards ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2022
29 days - 2
FDA Approval
4/29/2022
Other devices from Siemens Medical Solutions USA Inc.
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