SIGNA Artist Evo
GE Healthcare(Tianjin) Company LimitedThe SIGNA Artist Evo is a whole-body magnetic resonance imaging (MRI) scanner designed to provide high resolution and high signal-to-noise ratio images with short scan times. It supports imaging multiple body regions such as the head, spine, heart, abdomen, pelvis, and musculoskeletal systems. The images produced help clinicians diagnose a wide range of medical conditions based on molecular and anatomical information from MRI signals.
Intended Use
The SIGNATM Artist Evo 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. Depending on the region of interest being imaged, contrast agents may be used.
Technology
The system features a superconducting magnet, up to 128 independent receive channels, and uses time varying magnetic fields (gradients) and RF transmissions to obtain spatial and molecular information regarding nuclei exhibiting magnetic resonance. It employs various pulse sequences and reconstruction algorithms to produce images in multiple planes. The system reuses GE Healthcare 1.5T LCC magnets and introduces a new IRMW gradient coil. Software is mostly unchanged from the predicate device with minor adaptations for new hardware.
Performance
The device underwent risk management and performance testing including compliance with voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI 62304, and ISO 10993-1. Testing also included usage of applicable NEMA MS standards for MRI and DICOM compliance. No clinical studies were required; image quality was demonstrated to be substantially equivalent to the predicate device with sample clinical images provided. Quality assurance activities covered risk analysis, design reviews, various levels of testing including system and simulated use testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/15/2021
2 months - 2
FDA Approval
2/11/2022
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.