SIGNA Premier
GE Medical Systems, LLCThe SIGNA Premier is a whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution and high signal-to-noise ratio images in short scan times. It supports imaging of multiple body regions including the head, spine, breast, heart, abdomen, and musculoskeletal system, and uses advanced software featuring deep learning algorithms to automate steps in brain MRI examinations, thereby helping clinicians improve workflow and diagnostic consistency.
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 head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. Depending on the region of interest, contrast agents may be used. The images reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance to assist in diagnosis.
Technology
The device features a 3.0T superconducting magnet with a 70cm bore size capable of imaging in multiple planes and uses various pulse sequences, imaging techniques and reconstruction algorithms. The system conforms to DICOM standards and includes the AIRx software feature, developed using deep learning algorithms, which automates and standardizes a number of steps required for an MRI examination of the brain.
Performance
Performance testing included both bench and clinical testing to demonstrate that the modified SIGNA Premier with AIRx software maintains imaging performance equivalent to the predicate device. Software development followed quality assurance design controls, complied with relevant standards (IEC 62304, ANSI/AAMI 60601-1, IEC 60601-2-33), and validation scans showed productivity and consistency benefits of AIRx.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/20/2018
1 month - 2
FDA Approval
1/18/2019
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