Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250436
    Device Name
    MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
    Manufacturer
    Siemens Shenzhen Magnetic Resonance Ltd.
    Date Cleared
    2025-06-16

    (122 days)

    Product Code
    LNH, LNI, MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Shenzhen Magnetic Resonance Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 that displays, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
    Device Description
    MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are 60cm-bore MRI systems with quench pipe-free, sealed magnets utilizing DryCool technology. They are equipped with BioMatrix technology and run on Siemens' syngo MR XA70A software platform. The systems include Eco Power Mode for reduced energy and helium consumption. They have different gradient configurations suitable for all body regions, with stronger configurations supporting advanced cardiac imaging. Compared to the predicate device, new hardware includes a new magnet, gradient coil, RF system, local coils, patient tables, and computer systems. New software features include AutoMate Cardiac, Quick Protocols, BLADE with SMS acceleration for non-diffusion imaging, Deep Resolve Swift Brain, Fast GRE Reference Scan, Ghost reduction, Fleet Reference Scan, SMS Averaging, Select&GO extension, myExam Spine Autopilot, and New Startup-Timer. Modified features include improvements for Pulse Sequence Type SPACE, improved Gradient ECO Mode Settings, and Inline Image Filter switchable for users.
    Ask a Question

    Page 1 of 1