SIGNA Prime
GE Healthcare (Tianjin) Company LimitedSIGNA Prime is a whole body magnetic resonance imaging (MRI) scanner that supports high resolution and fast scan times. It produces detailed images and spectroscopic data of various body regions, helping clinicians diagnose a wide range of conditions by showing the spatial distribution and molecular environment of tissues.
Intended Use
SIGNA Prime is a whole body magnetic resonance scanner indicated for use as a diagnostic imaging device to produce images and spectroscopic data of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. It produces images reflecting the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance, aiding diagnosis.
Technology
SIGNA Prime uses a 1.5T superconducting magnet with a 60cm bore size and combines time-varying magnetic fields (Gradients) and RF transmissions to acquire MRI data in multiple planes. It features new Gradient Driver, RF transmit and receive architecture, and software platform application suite, designed according to NEMA DICOM standards.
Performance
The device underwent comprehensive non-clinical testing including standards for safety, electromagnetic compatibility, and software quality (ANSI/AAMI ES60601-1, IEC 60601 series, IEC 62304, ISO 10993). Clinical images demonstrated acceptable diagnostic image quality equivalent to predicate devices. No new clinical studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/25/2021
6 months - 2
FDA Approval
1/16/2022
Other devices from GE Healthcare (Tianjin) Company Limited
- SIGNA Champion2024 • 510K
- SIGNA Victor2023 • 510K
- SIGNA Artist2020 • 510K
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