MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

The MAGNETOM Vida, Lumina, Vida Fit, Sola, Altea, Sola Fit, Viato.Mobile, Flow.Elite, Flow.Neo, and Flow.Rise are magnetic resonance diagnostic devices (MRDDs) that produce cross-sectional images and spectroscopic data of the head, body, and extremities. They display internal structure and function to assist in diagnosis, and may be used for interventional procedures with MR-compatible devices.

The subject devices contain new and modified hardware (myExam 3D Camera, BM Contour XL Coil, RF Transmitter TBX3, MaRS system) and software (Syngo MR XB10) with new features including Deep Resolve artificial intelligence algorithms, brachytherapy support, cardiac imaging automation, and various pulse sequence enhancements. While technological differences exist, testing demonstrates equivalent safety and performance to predicate devices.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, ISO 14971, ISO 10993-1, NEMA MS 4-2010, NEMA MS 9-2008, and NEMA DICOM PS 3.1-3.20.

The subject devices have the same intended use and basic technological characteristics as predicate devices (MAGNETOM Vida/Lumina XA60A, Sola/Altea XA61A, and Sola Fit/Viato.Mobile XA70A). Nonclinical testing including software verification, image quality assessment, and performance benchmarking demonstrate equivalent safety and performance profiles, supporting substantial equivalence despite hardware and software modifications.