SIGNA Hero
GE Healthcare (GE Medical Systems, LLC)SIGNA Hero is a whole body 3.0 Tesla MRI scanner from GE Healthcare that supports high resolution images with a high signal-to-noise ratio and short scan times. It produces detailed images of structures and functions throughout the body to aid physicians in diagnosis by providing axial, sagittal, coronal and oblique images, along with spectroscopic and dynamic imaging capabilities.
Intended Use
The SIGNA Hero 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 Hero 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
SIGNA Hero employs time-varying magnetic gradient fields and radiofrequency transmissions to obtain spatial information of nuclei exhibiting magnetic resonance. It features a 3.0T superconducting magnet with a 70 cm bore, supports multiple imaging planes and pulse sequences, and conforms to NEMA DICOM standards. It offers two magnet configurations including a newly designed 3.0T ARES platform magnet, and builds upon existing GE Healthcare gradient driver, RF transmitter, and software designs.
Performance
The SIGNA Hero underwent non-clinical testing including safety and performance bench tests compliant with standards like ANSI/AAMI ES60601-1, IEC 60601 series, IEC 62304, ISO 10993-1, and IEC 62464-1. It shares a biocompatibility track record with predicate devices and passed risk analysis, design reviews, module and system verification, and validation tests. Clinical studies were not required; illustrative clinical images demonstrate diagnostic image quality substantially equivalent to the predicate device (SIGNA Pioneer, K160621).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2021
1 month - 2
FDA Approval
1/20/2022
Other devices from GE Healthcare (GE Medical Systems, LLC)
- Precision DL2023 • 510K
- Xeleris V Processing and Review System2023 • 510K
- Voluson P6, Voluson P82022 • 510K
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.