SIGNA 7.0T
GE Medical Systems, LLCThe SIGNA 7.0T is a high-performance whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution images with high signal-to-noise ratio and short scan times. It supports imaging of the head and extremities in multiple planes and includes AI-driven image reconstruction software called AIR Recon DL, which enhances image quality by improving signal-to-noise ratio and sharpness without compromising low contrast detectability. This aids clinicians by providing clearer images for more accurate diagnoses.
Intended Use
The SIGNA 7.0T system is a whole-body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the head and extremities. The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The device is intended for patients > 20 kg / 44 lb.
Technology
The system includes a 7.0T superconducting magnet and an ultra-high performance gradient coil with a 60 cm patient bore. It supports scanning in multiple planes using a variety of pulse sequences, imaging techniques, acceleration methods, and reconstruction algorithms. The AIR Recon DL software feature provides image noise reduction and improves image sharpness and signal-to-noise ratio, resulting in higher quality images without sacrificing low contrast detectability.
Performance
Nonclinical testing demonstrated improved image signal-to-noise ratio (SNR) and sharpness, maintaining low contrast detectability and image quality without adverse effects. Clinical reader studies confirmed that AIR Recon DL images provide better or equivalent sharpness and improved SNR, with radiologists preferring these images for clinical evaluation. Simulations ensured upgrades are compatible with existing 7.0T magnets in the installed base.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/15/2021
28 days - 2
FDA Approval
5/13/2021
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