uMR Omega

The uMR Omega, an established 3.0T superconducting magnetic resonance imaging system, provides detailed anatomical and functional images for comprehensive diagnostic support across various body regions. This update introduces a 24-channel breast coil, representing a technological enhancement focused on optimizing radiofrequency signal reception for potentially improved breast imaging, while the core MR imaging methodology and scientific principles of the device remain consistent with its predicate.

The uMR Omega is an existing 3.0 Tesla superconducting magnetic resonance diagnostic device (MRDD) featuring a 75cm patient bore. It is designed to generate various types of images, including sagittal, transverse, coronal, and oblique cross-sectional images, along with spectroscopic images, to visualize internal anatomical structures and functions of the head, body, and extremities. These images, when interpreted by a trained physician, serve as a diagnostic aid, with the option to use contrast agents based on the specific scan and region of interest. The system architecture includes a magnet, RF and gradient systems, patient table, spectrometer, and computer, and it conforms to NEMA and DICOM standards. This submission details a modification to the previously cleared uMR Omega (K230152), specifically the introduction of a new 'Breast Coil-24'. This addition aims to enhance breast imaging capabilities without altering the device's fundamental scientific technology or its overall intended use. The primary technological difference in this modification is the increase in the number of receiver channels in the breast coil (24 channels) compared to a previous version (Breast Coil-10). Comprehensive performance testing—including surface heating, electrical/mechanical safety, Signal-to-Noise Ratio (SNR) and uniformity, biocompatibility of identical materials, Electromagnetic Compatibility (EMC), and clinical image quality evaluation specifically for the Breast Coil-24—confirmed that the modified device meets design specifications and provides diagnostically sufficient image quality.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the increased number of channels in the Breast Coil-24 (from a previous 10-channel version) quantitatively affect key imaging parameters like signal-to-noise ratio (SNR), spatial resolution, and parallel imaging acceleration factors specifically for breast MRI?; What specific types of breast pathologies or imaging sequences are anticipated to benefit most significantly from the increased channel count of the Breast Coil-24?; Were any modifications made to the image reconstruction algorithms or system software of the uMR Omega to optimize performance with the higher channel density of the Breast Coil-24?; What are the practical implications for clinical workflow, such as patient setup time or overall scan duration, with the introduction of the Breast Coil-24 compared to using the previous Breast Coil-10 or other standard coils?; What were the specific acceptance criteria for the 'clinical image quality' evaluation of the Breast Coil-24, particularly concerning its ability to visualize subtle lesions or diverse breast tissue types, as assessed by the U.S. Board Certified radiologist?