SIGNA Champion

The SIGNATM Champion is a 1.5T whole-body magnetic resonance scanner engineered for comprehensive diagnostic imaging, providing high-resolution images, high signal-to-noise ratios, and reduced scan times through its advanced hardware components and deep learning-based software like Sonic DL and AIR Recon DL. Its methodology relies on detecting magnetic resonance signals from nuclei within the body using time-varying magnetic fields and RF pulses to generate a wide array of image types, including spectroscopic and dynamic studies, to aid physicians in diagnosis.

The SIGNATM Champion is a 1.5 Tesla whole-body magnetic resonance (MR) scanner designed to produce high-resolution diagnostic images with high signal-to-noise ratios and short scan times. It is indicated for use in imaging the entire body—including head, neck, spine, heart, abdomen, pelvis, joints, and musculoskeletal regions—producing axial, sagittal, coronal, oblique images, as well as spectroscopic images, parametric maps, spectra, and dynamic images of anatomical structures and functions. The system utilizes time-varying magnetic fields and radiofrequency (RF) transmissions to capture information about the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance, and can be used with contrast agents depending on the imaging needs. The SIGNATM Champion incorporates several hardware modifications compared to its predicate (SIGNATM Voyager), including a new magnet enclosure, patient table, host computer, RF transmit chain (featuring an In Scan Room architecture from a reference device), and wireless gating capabilities. It also introduces advanced software features such as Sonic DL and AIR Recon DL, similar to those in a reference device (SIGNATM Hero), which are deep learning-based reconstruction algorithms. While employing the same fundamental scientific MR technology as its predicate, these enhancements aim to improve performance and user experience. Bench testing and sample clinical images were used to demonstrate acceptable diagnostic image quality, comparable to the predicate device.

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 Sonic DL and AIR Recon DL quantitatively impact specific image quality metrics (e.g., SNR, CNR, spatial resolution, artifact reduction) and scan time efficiency across different anatomical regions and pulse sequences compared to conventional reconstruction techniques on GE systems?; What are the measurable benefits of the redesigned patient table and magnet enclosure in terms of patient comfort, throughput, or accessibility for diverse patient populations (e.g., bariatric, claustrophobic)?; For which specific clinical applications or challenging imaging scenarios (e.g., motion-prone patients, complex anatomies) do the new hardware and software features of SIGNATM Champion offer the most significant diagnostic advantages over the SIGNATM Voyager?; What specific bench testing methodologies and phantom studies were conducted to validate the performance of the modified RF transmit chain and the wireless gating system, particularly concerning signal integrity and SAR management?; Can GE Healthcare provide comparative image sets from the SIGNATM Champion and the predicate SIGNATM Voyager, acquired under identical conditions for specific clinical indications, to allow for an independent assessment of the claimed substantial equivalence in diagnostic image quality?