uMR Omega

The uMR Omega is a 3.0 Tesla superconducting magnetic resonance imaging system that produces cross-sectional and spectroscopic images of the head, body, and extremities to display internal anatomical structure and function. Images and derived physical parameters, when interpreted by a trained physician, may assist diagnosis; contrast agents may be used as needed.

The proposed device maintains identical magnet specifications (3.0T, 75 cm bore, superconducting, actively shielded with OIS technology), gradient system (45 mT/m, 200 T/m/s), and RF system (128.23 MHz, 2 transmit, 96 receive channels) as the predicate. Changes include addition of new RF coils (Breast Coil-12, Head Coil-16, Tx/Rx Head Coil), minor table dimension modifications, component name change (mmw100 to mmw101), new pulse sequences (gre_pass, gre_mtp, epi_dti_msh, gre_fsp_c), and new software features (SparkCo artifact correction, Inline ECV, Inline MOCO, Breast Biopsy workflow).

Conformance claimed to IEC 60601-1-2:2014, IEC 60601-2-33:2022, NEMA MS 1-9 and MS 14-2019 (SNR, geometric distortion, uniformity, acoustic noise, SAR, slice thickness, coil heating), IEC 62304 (software lifecycle), ISO 14971 (risk management), and 21 CFR Part 820 (quality system regulation).

The device employs identical fundamental magnetic resonance technology, field strength, bore size, and core hardware specifications as the predicate device with the same indications for use. New components (RF coils, software features) do not raise safety or effectiveness concerns because they are either functionally equivalent to previously cleared components (e.g., Breast Coil-12 vs. Breast Coil-10) or represent non-invasive image processing enhancements (e.g., SparkCo, Inline ECV). Clinical image samples reviewed by a board-certified radiologist confirmed diagnostic quality equivalent to the predicate. Non-clinical testing including surface heating and image performance verified design specifications and conformance to applicable standards.