MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

The MAGNETOM Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile are magnetic resonance diagnostic devices that produce cross-sectional images and spectroscopic data of the head, body, or extremities to assist in clinical diagnosis. They can be used for standard MRI imaging and interventional procedures with MR-compatible accessories.

The subject devices incorporate new and modified software (syngo MR XA70A) and hardware compared to predicates. New hardware includes the myExam 3D Camera and BM Head/Neck 20 coil. New software features include myExam Autopilot Brain/Knee, 3D Whole Heart, Deep Resolve Gain/Sharp/Boost algorithms, Ghost Reduction, BLADE diffusion, and AutoMate Cardiac. Modified features include SPACE improvements, Brain Assist, and Eco power mode. The fundamental magnet, RF, gradient, and patient table systems remain essentially unchanged.

Devices conform to IEC 62304 (medical device software lifecycle), IEC 60601-1-2 (electromagnetic safety), IEC 60601-2-33 (MR equipment safety), ISO 14971 (risk management), ISO 62366-1 (usability), NEMA MS 6-2008 (SNR/uniformity for coils), and NEMA DICOM PS 3.1-3.20 (digital imaging standards).

The subject devices share identical intended use and basic technological architecture with their predicates across all four models. Although new AI-based features (Deep Resolve algorithms, AutoMate Cardiac), pulse sequences (BLADE diffusion, GRE_PC), and hardware (3D camera, new coil) are present, comprehensive nonclinical testing—including software verification/validation, sample clinical image assessment, coil performance benchmarking, and AI training/validation on large datasets—demonstrated that these features achieve equivalent safety and performance profiles to the predicate devices. The differences represent incremental enhancements within the same fundamental MR imaging platform, not fundamental design changes.