MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc.The MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, and MAGNETOM Altea are magnetic resonance imaging systems designed to produce detailed cross-sectional images and spectra of the head, body, and extremities. These systems aid clinicians in diagnosis by providing high-quality images and offer specialized features such as interventional imaging support and automated workflows, improving reproducibility and efficiency.
Intended Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device producing cross sectional images, spectroscopic images, and spectra of the head, body, or extremities to assist in diagnosis.
Technology
The device includes new and modified hardware and software components compared to the predicate. Hardware includes new coil designs, a dockable table for intraoperative use, and new sensors for cardiac triggering. Software improvements include new pulse sequences, image reconstruction algorithms based on convolutional neural networks, and workflow automation for prostate imaging and contrast injector coupling.
Performance
Performance testing included image quality assessment via clinical images, bench tests of new hardware, and software validation. Biocompatibility and safety tests were also conducted. No additional clinical studies were performed, but referenced clinical publications support functionality of specific features.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2020
4 months - 2
FDA Approval
3/31/2021
Other devices from Siemens Medical Solutions USA, Inc.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.