MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

The MAGNETOM Flow.Ace and Flow.Plus are 1.5T magnetic resonance diagnostic devices that produce cross-sectional images and spectroscopic data of the head, body, and extremities. They are indicated for diagnostic imaging and can be used during interventional procedures with MR-compatible devices. Images and derived parameters, when interpreted by trained physicians, assist in diagnosis.

Both devices feature new 60cm-bore magnets with DryCool quench pipe-free technology, new gradient coils, RF systems, local coils, patient tables, and computer systems compared to the predicate MAGNETOM Sola. Software includes new features such as AutoMate Cardiac, Deep Resolve Swift Brain, BLADE with SMS acceleration, and myExam Spine Autopilot, plus modifications to SPACE pulse sequences and gradient ECO modes. Different gradient configurations between Flow.Ace and Flow.Plus enable expanded applications including advanced cardiac imaging.

Devices conform to IEC 60601-1 and 60601-1-2 (electrical safety and EMC), IEC 60601-2-33 (MR equipment safety), ISO 14971 (risk management), IEC 62304 (software life cycle), ISO 62366-1 (usability), NEMA MS 4-2010 (acoustic noise), NEMA MS 9-2008 (phased array coil characterization), NEMA DICOM PS 3.1–3.20 (digital imaging standards), and ISO 10993-1 (biocompatibility).

The subject devices have the same intended use and basic MR diagnostic functionality as the predicate MAGNETOM Sola. Although hardware components (magnet, gradients, coils, tables) are new and software features are enhanced, performance testing including sample clinical images, SNR and uniformity measurements, heating assessments, and software verification demonstrate equivalent safety and performance profiles. AI features underwent training and validation with large datasets and quality metrics (PSNR, SSIM, NMSE). Risk management via ISO 14971 and adherence to recognized electrical and mechanical standards provide equivalent safety margins.