MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.The MAGNETOM Viato.Mobile by Siemens is a 1.5 Tesla mobile MRI system designed to be relocated to different locations where imaging services are needed. It produces high-quality MR images of the head, body, and extremities in multiple planes and can also be used during interventional procedures. This helps clinicians diagnose a variety of conditions by providing detailed internal anatomical and functional imaging.
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.
Technology
MAGNETOM Viato.Mobile is a mobile 1.5 T MR system with syngo MR XA51A software, featuring minor hardware changes compared to the predicate device, adapted for installation in a mobile trailer to enable relocation of the MRI system to different locations.
Performance
Performance bench tests and verification were performed on modified hardware, electrical safety and electromagnetic compatibility testing were completed on the full system, demonstrating equivalent performance and safety to the predicate device. No clinical testing was conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/16/2023
21 days - 2
FDA Approval
9/6/2023
Other devices from Siemens Medical Solutions USA, Inc.
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