SIGNA Prime

The SIGNA Prime is a whole-body magnetic resonance scanner designed to produce high-resolution diagnostic images with high signal-to-noise ratios and short scan times across a wide range of anatomical regions. It achieves this through a 1.5T superconducting magnet and newly designed components including the gradient driver, RF transmit/receive architecture, and a new software suite, all based on the principles of magnetic resonance.

The SIGNA Prime is a whole-body magnetic resonance (MR) scanner designed to support diagnostic imaging with high resolution, a high signal-to-noise ratio, and short scan times. It is indicated for producing a variety of image types, including axial, sagittal, coronal, and oblique images, as well as spectroscopic images, parametric maps, and dynamic images of structures and functions throughout the entire body. Specific applications cover areas such as the head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. The system allows for the use of contrast agents depending on the imaging needs, and the images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance, providing information to assist physicians in diagnosis. The SIGNA Prime system operates based on the fundamental scientific principles of magnetic resonance, employing a 1.5T superconducting magnet with a 60cm bore. Its technology builds upon predicate devices but incorporates notable advancements, including a 1.5T IPM magnet, a newly designed Gradient Driver, a new RF transmit architecture, a new RF receiving chain, and a new software platform application suite. These components work together by utilizing time-varying magnet fields (gradients) and RF transmissions to obtain information about the density and position of elements exhibiting magnetic resonance. The system can image in various planes and uses different pulse sequences, imaging techniques, and reconstruction algorithms, conforming to NEMA DICOM standards for digital imaging and communications in medicine.

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 do the 'newly designed Gradient Driver, RF transmit architecture, and RF receiving chain' specifically contribute to improved image quality (e.g., resolution, signal-to-noise ratio) or reduced scan times compared to the predicate device SIGNA Creator?; What are the specific advantages or new capabilities introduced by the 'new software platform application suite' in terms of image processing, workflow efficiency, or novel diagnostic functionalities?; Are there particular anatomical regions or pathologies where the SIGNA Prime's technological enhancements (e.g., 1.5T IPM magnet, new RF systems) are expected to offer a demonstrable clinical advantage over other 1.5T systems, including its predicate?; Beyond the provision of 'sample clinical images,' what quantitative imaging metrics (e.g., SNR, CNR, spatial resolution measurements) from bench testing or phantom studies support the claim of equivalent or improved diagnostic image performance compared to the SIGNA Creator?; Given the newly designed components such as the gradient driver and RF architecture, what is the comparative acoustic noise profile of the SIGNA Prime during typical imaging sequences, and what, if any, specific noise reduction technologies are integrated?