MAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc.The MAGNETOM Avanto Fit is a 1.5 Tesla magnetic resonance imaging (MRI) system that produces detailed images of the head, body, and extremities. It helps clinicians visualize internal structures and functions non-invasively, potentially including functional information, and can be used during interventional procedures. The device incorporates advanced hardware and software features to enhance image quality and operational efficiency.
Intended Use
MAGNETOM Avanto Fit is indicated as a magnetic resonance diagnostic device producing cross-sectional images and spectra of the head, body, or extremities, assisting diagnosis when interpreted by a physician. It can also be used during interventional procedures with MR compatible devices.
Technology
MAGNETOM Avanto Fit integrates new and modified hardware and software compared to its predicate device including advanced motion correction, automatic fiducial detection for breast biopsy, and an absolute shimming mode, implemented on a 1.5 T MRI platform with updated electronics and BioMatrix components.
Performance
Performance testing included sample clinical images comparing new and modified pulse sequences with the predicate, hardware bench tests, and software verification and validation. Standards IEC 60601-1 and IEC 60601-2-33 were met with no safety or effectiveness concerns identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/19/2022
2 months - 2
FDA Approval
4/1/2022
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.