SIGNA Prime Elite
GE Medical Systems, LLCThe SIGNA Prime Elite is a whole body magnetic resonance imaging (MRI) scanner that offers high resolution and short scan times. It produces detailed images across multiple planes of the entire body, including the head, spine, heart, and musculoskeletal regions, assisting physicians in diagnostic interpretation to support detection and evaluation of various medical conditions.
Intended Use
The SIGNA Prime Elite 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 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 Prime Elite uses a 1.5T superconducting magnet with a 60 cm bore size. It acquires images using time-varying magnetic gradients and RF transmissions, and utilizes various pulse sequences, imaging techniques, and reconstruction algorithms. The device conforms to NEMA DICOM standards. It employs hardware subsystems including magnet, gradient coil, RF transmit and receive subsystems, and detachable coils for all anatomies. Software features include a comprehensive suite supporting MR imaging of all anatomies. The technology is substantially equivalent to predicate devices SIGNA Victor and SIGNA Champion, with no significant software changes.
Performance
The SIGNA Prime Elite underwent extensive non-clinical testing to demonstrate safety and performance equivalence including standards ANSI AAMI ES60601-1, IEC 60601 series, IEC 62304, IEC 62366-1, and ISO 10993-1. The device complies with applicable NEMA MS and PS3 DICOM standards. Testing included risk analysis, design reviews, module and system verification, and simulated use validation. Clinical imaging data demonstrated image quality substantially equivalent to predicate devices without requiring new clinical studies.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/11/2025
1 month - 2
FDA Approval
3/17/2025
Other devices from GE Medical Systems, LLC
- Revolution Vibe2025 • 510K
- Sonic DL2025 • 510K
- SIGNA MAGNUS2024 • 510K
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