SIGNA Victor
GE Healthcare (Tianjin) Company LimitedThe SIGNA Victor is a 1.5 Tesla whole body MRI scanner designed to provide high-resolution diagnostic images quickly and with a high signal-to-noise ratio. It produces images in multiple planes and supports imaging of the entire body, including brain, spine, joints, heart, abdomen, and more, aiding clinicians in diagnosing a variety of conditions.
Intended Use
The SIGNA Victor 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.
Technology
The SIGNA Victor uses a 1.5T superconducting magnet with a 60 cm bore size, RF transmit and receive architecture, and software for image reconstruction. It acquires data using time-varying magnetic gradients and RF transmissions to image nuclei exhibiting magnetic resonance, producing images in multiple planes and conforming to NEMA DICOM standards.
Performance
The SIGNA Victor complied with extensive non-clinical risk management, safety, and performance tests in accordance with various voluntary standards including ANSI AAMI ES60601-1, IEC 60601 series, IEC 62304, IEC 62366-1, ISO 10993-1, and NEMA standards for MRI and DICOM. Clinical studies were not required as image quality was demonstrated equivalent to predicate devices through sample clinical images and bench testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2022
3 months - 2
FDA Approval
2/13/2023
Other devices from GE Healthcare (Tianjin) Company Limited
- SIGNA Champion2024 • 510K
- SIGNA Prime2022 • 510K
- SIGNA Artist2020 • 510K
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