SIGNA Artist
GE Healthcare (Tianjin) Company LimitedSIGNA Artist is a magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images of the whole body. It supports multiple imaging planes and can generate a variety of images including axial, sagittal, coronal, spectroscopic, parametric maps, and dynamic images. The AIR Recon DL software feature enhances image quality by improving signal-to-noise ratio and sharpness, assisting clinicians in diagnosis through clearer MRI images.
Intended Use
The SIGNA Artist 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 entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Artist system 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.
Technology
The SIGNA Artist system is a whole body magnetic resonance scanner featuring a superconducting magnet, data acquisition system with up to 128 independent receive channels, and multiple coil elements per channel. It uses time varying magnetic fields and RF transmissions for imaging in multiple planes with various pulse sequences and reconstruction algorithms. The AIR Recon DL software feature provides options for image noise reduction, resulting in images with higher signal-to-noise ratio and improved sharpness compared to images without this feature.
Performance
Nonclinical testing showed that AIR Recon DL improves signal-to-noise ratio and image sharpness, maintains low contrast detectability, and does not introduce significant bias or negatively affect image quality. Clinical testing with radiologists confirmed improved or equivalent image quality and preferred AIR Recon DL images for clinical use. The combined testing supported that the device is safe and effective, enabling shorter scan times with maintained image quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/7/2020
28 days - 2
FDA Approval
9/4/2020
Other devices from GE Healthcare (Tianjin) Company Limited
- SIGNA Champion2024 • 510K
- SIGNA Victor2023 • 510K
- SIGNA Prime2022 • 510K
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