SIGNA 7.0T

The SIGNA 7.0T system is designed to provide superior diagnostic imaging of the head and extremities by leveraging a 7.0 Tesla magnetic field, advanced RF transmit/receive technology, and a high-performance gradient system. Its methodology involves utilizing optimized pulse sequences and the SIGNA Works application suite to produce high-resolution, high signal-to-noise ratio images, including structural, functional, and spectroscopic data, for improved clinical diagnosis.

The SIGNA 7.0T is a high-performance magnetic resonance imaging (MRI) system designed for diagnostic imaging, featuring a 7.0 Tesla superconducting magnet and a 60 cm patient bore. It aims to provide high-resolution images with a high signal-to-noise ratio and short scan times, focusing on the head and extremities for patients weighing over 20 kg (44 lb). The system can produce axial, sagittal, coronal, and oblique images, as well as spectroscopic images, parametric maps, and dynamic images of anatomical structures and physiological functions. These outputs, reflecting the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance, are intended to assist trained physicians in diagnosis. Key technological advancements of the SIGNA 7.0T compared to its 3.0T predicate include its significantly higher B0 magnetic field strength, a sophisticated RF transmit chain with multiple independent channels and dedicated receiver array coils for enhanced signal reception, and a more powerful gradient system capable of 113 mT/m amplitude and 260 T/m/s slew rate. The system utilizes the SIGNA Works suite of applications, optimized for the 7.0T field strength, to generate detailed functional, structural, anatomical, vascular, and spectroscopic images. Clinical evaluations, including a reader study with U.S. board-certified radiologists comparing images from the 7.0T system to a 3.0T predicate for brain and knee scans, assessed diagnostic image quality and usability, with PNS limits established through studies on healthy adult volunteers.

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 gradient amplitude (113 mT/m) and slew rate (260 T/m/s) of the SIGNA 7.0T specifically contribute to improved image resolution or reduced scan times for head and extremity imaging compared to a 3.0T system?; What specific "common neuropathologies" were included in the reader evaluation study, and were there any notable differences in diagnostic confidence or image quality for these specific conditions when using the 7.0T system versus the 3.0T predicate?; Can the SIGNA Works suite of applications be customized or expanded for novel research sequences, particularly for functional and spectroscopic imaging at 7.0T?; What are the quantitative improvements in signal-to-noise ratio (SNR) observed with the SIGNA 7.0T for specific anatomical regions (e.g., brain, knee) compared to the 3.0T predicate, as demonstrated in the clinical tests?; Are there any specific contraindications or patient safety considerations unique to imaging at 7.0T with the SIGNA 7.0T system, beyond general MRI contraindications and the stated patient weight limit of >20kg?