SIGNA Premier
GE Healthcare (GE Medical Systems, LLC)The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.
Intended Use
The SIGNA Premier 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.
Technology
The device includes a 3.0T superconducting magnet with a 70cm bore, gradient coils, RF transmit and receive subsystems, patient support table, host computer, and system software. The AIR Recon DL feature uses deep learning for image reconstruction, improving SNR and sharpness, allowing shorter scan times without hardware changes.
Performance
Nonclinical testing with a digital reference object and phantom imaging showed AIR Recon DL improves SNR and image sharpness while maintaining low contrast detectability and minimal noise impact. Clinical testing with radiologist reader studies confirmed improved image quality and preference for AIR Recon DL images, with preserved lesion conspicuity. No significant safety or performance concerns were identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
4 months - 2
FDA Approval
4/10/2020
Other devices from GE Healthcare (GE Medical Systems, LLC)
- Precision DL2023 • 510K
- Xeleris V Processing and Review System2023 • 510K
- Voluson P6, Voluson P82022 • 510K
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