MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

The MAGNETOM Flow.Ace and MAGNETOM Flow.Plus with software Syngo MR XB10 are magnetic resonance diagnostic devices (MRDDs) that produce cross-sectional images, spectroscopic images, and spectra of the head, body, or extremities to assist in diagnosis. The devices can also be used for imaging during interventional procedures with MR-compatible devices such as in-room displays and MR Safe biopsy needles.

Compared to the predicate devices (with software syngo MR XA70A), the subject devices include new hardware such as a spine support respiratory cushion with new surface material, a new gradient configuration upgrade from B60 to G60, and a new BioMatrix Dockable Table with optional eDrive transferred from the reference device. Software additions include Open Workflow, Eco Power Mode Pro, PETRA with a new claim, and various improvements to sequences such as Deep Resolve Boost, SPAIR fat saturation modes, and BioMatrix Motion Sensor (SAMER).

The devices conform to IEC 60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2:2020 (electromagnetic disturbances), IEC 60601-2-33:2022 (MR equipment safety), ISO 14971:2019 (risk management), IEC 62304:2006 (software life cycle), ISO 10993-1:2018 (biocompatibility), NEMA MS 4-2010 (acoustic noise), NEMA MS 9-2008 (phased array coils), and NEMA DICOM standards.

The subject devices have the same intended use and basic technological characteristics as the predicate devices (MAGNETOM Flow.Ace and Flow.Plus with software syngo MR XA70A, K250436, cleared June 16, 2025). Although there are differences in hardware and software features, all new and modified features have been tested, and the non-clinical and clinical data demonstrate that these features bear equivalent safety and performance profiles to the predicate devices.