SIGNA Champion
GE Healthcare (Tianjin) Company LimitedThe SIGNA Champion is a 1.5 Tesla whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images quickly. It can image multiple body regions including the head, neck, spine, chest, abdomen, pelvis, joints, and more, using various scan planes and sequences to help physicians diagnose medical conditions. It supports advanced imaging techniques and uses standard MRI technology enhanced by new software and hardware components to improve image quality and workflow.
Intended Use
The SIGNA Champion 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 entire body including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions.
Technology
The SIGNA Champion utilizes a 1.5 Tesla superconducting magnet with a 70cm bore size, water-cooled gradient coils with active shielding, and RF transmit/receive subsystems. It employs advanced software features including AIR Recon DL and Sonic DL for image reconstruction and processing, supporting multiple pulse sequences and imaging planes. The scanner supports wireless gating accessories and complies with NEMA DICOM standards.
Performance
The device underwent extensive non-clinical testing including electrical safety, electromagnetic compatibility, software validation, biocompatibility, and image quality bench testing, demonstrating performance equivalent to the predicate device. Clinical testing was not required to establish substantial equivalence; however, sample clinical images were included showing acceptable diagnostic image quality comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2023
1 month - 2
FDA Approval
1/19/2024
Other devices from GE Healthcare (Tianjin) Company Limited
- SIGNA Victor2023 • 510K
- SIGNA Prime2022 • 510K
- SIGNA Artist2020 • 510K
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