SIGNA 7.0T
GE Medical Systems, LLCThe SIGNA 7.0T is a high-performance whole-body MRI scanner designed by GE Healthcare to produce high-resolution images of the head and extremities. It supports multiple imaging techniques and pulse sequences to generate detailed anatomical, functional, spectroscopic, and vascular images. The device helps clinicians in diagnosis by delivering high signal-to-noise ratio images with shorter scan times, particularly enabled by its advanced 7.0 Tesla magnetic field strength and optimized hardware.
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.
Technology
The SIGNA 7.0T employs a 7.0T superconducting magnet, an ultra-high performance gradient coil (maximum gradient amplitude 113 mT/m and slew rate of 260 T/m/s), and multiple independent RF transmission channels with dedicated receiver array coils for high sensitivity signal reception. It uses the SIGNA Works suite of advanced applications optimized for higher field strength and supports various pulse sequences, acceleration methods, and reconstruction algorithms.
Performance
The device underwent extensive bench and clinical testing, including safety and performance tests to voluntary standards (ANSI/AAMI, IEC, ISO). Clinical testing involved radiologist reader studies comparing image quality and diagnostic usability of 7.0T images to 3.0T predicate images, demonstrating the device's safety and effectiveness with no new hazards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/15/2020
4 months - 2
FDA Approval
10/15/2020
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