MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbHThe MAGNETOM Avanto Fit, MAGNETOM Skyra Fit, MAGNETOM Sola Fit, and MAGNETOM Viato.Mobile are MRI systems designed to produce detailed diagnostic images and spectra of the head, body, and extremities. They include advanced AI-based features such as Deep Resolve Boost and Deep Resolve Sharp to enhance image quality and speed, aiding radiologists in diagnosis and treatment planning.
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 displays the internal structure and/or function of the head, body, or extremities. Contrast agents may be used depending on region of interest. It may also be used for imaging during interventional procedures.
Technology
The devices use software syngo MR XA70A with new and modified hardware such as a myExam 3D Camera and Sanaflex cushions for positioning. AI-based features like Deep Resolve Boost and Deep Resolve Sharp improve image reconstruction and quality. They support advanced MR pulse sequences (SE, GRE, EPI) and conform to standards IEC 62304, IEC 60601-1, ISO 14971 among others.
Performance
Nonclinical testing including software verification, sample clinical image comparisons, and performance bench tests for hardware components showed that the new features have equivalent safety and performance to predicate devices. AI features Deep Resolve Boost and Sharp were trained and validated on large datasets (>10,000 slices) covering diverse body parts with metrics like PSNR and SSIM demonstrating improved image quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/14/2025
4 months - 2
FDA Approval
6/16/2025
Other devices from Siemens Healthcare GmbH
- AI-Rad Companion Organs RT2025 • 510K
- Prostate MR AI (VA10A)2025 • 510K
- Syngo Carbon Enterprise Access (VA40A)2024 • 510K
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