SIGNA Victor

The SIGNATM Victor is a whole-body magnetic resonance diagnostic device engineered to produce a comprehensive suite of high-resolution images, spectroscopic data, and dynamic functional visuals across diverse anatomical regions. It operates on the principles of nuclear magnetic resonance, utilizing a 1.5T superconducting magnet, time-varying gradients, and RF transmissions, with its performance in generating diagnostically useful images supported by non-clinical testing and sample clinical image review.

The SIGNA Victor is a whole-body magnetic resonance scanner designed to support high-resolution, high signal-to-noise ratio, and short scan times for comprehensive diagnostic imaging. Its indications for use cover the entire body, including head, neck, spine, breast, heart, abdomen, pelvis, joints, prostate, and blood vessels, enabling the production of axial, sagittal, coronal, and oblique images, as well as spectroscopic images, parametric maps, and dynamic functional images. The system allows for the use of contrast agents depending on the imaging needs, and the resulting images, which reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance, are intended for interpretation by trained physicians to aid in diagnosis. The device operates using a 1.5T superconducting magnet with a 60cm bore and employs a combination of time-varying magnet fields (gradients) and radiofrequency (RF) transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. It can image in various planes using different pulse sequences, imaging techniques, and reconstruction algorithms. The system architecture includes the superconducting magnet, RF transmit architecture, RF receive chain, and a software application suite, all designed to conform to NEMA DICOM standards. Non-clinical tests against standards such as IEC 60601-1, IEC 60601-2-33, and ISO 10993-1, along with sample clinical images, have demonstrated acceptable diagnostic image performance.

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 SIGNA Victor's software application suite differ from or improve upon those of the predicate devices, SIGNA Explorer and SIGNA Prime, in terms of image processing algorithms or user interface?; What specific advancements in the RF receive chain contribute to the claimed high signal-to-noise ratio and short scan times in the SIGNA Victor compared to its predecessors?; Are there specific pulse sequences or imaging techniques unique to the SIGNA Victor that enable enhanced imaging for particular anatomical regions or pathologies mentioned in its indications for use?; Given that no new clinical studies were referenced, what was the scope and nature of the 'sample clinical images' provided, and how did they definitively demonstrate comparable diagnostic image performance across the broad range of indicated body parts?; How does the 60cm bore size of the SIGNA Victor impact patient comfort and accessibility for diverse patient populations, and are there any performance trade-offs associated with this bore size compared to systems with larger or smaller bores?