Magnetic Resonance Imaging System
Vietnam·Risk Class TTBYT Loại B·SIGNA Premier·GE Healthcare Manufacturing LLC·Registered Sep 15, 2022- Analysis ID
- 220003034/PCBB-HN
- Submission ID
- 000.00.19.H26-220810-0017
- Product Type
- SIGNA Premier
- Manufacturer
- GE Healthcare Manufacturing LLC
- Intended Use
- The SIGNA™ Premier system is a whole-body MRI scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated as a diagnostic imaging device to produce images of the axial, sagittal, coronal, and oblique planes, spectroscopy, parameter maps and/or dynamic, spectroscopic images of the structures and/or functions of the entire body, including, but not limited to, the head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and the musculoskeletal regions of the body. Depending on the area of interest being imaged, contrast agents may be used. The images produced by the SIGNA™ Premier system reflect the spatial distribution or the molecular environment of the nuclei, which are the source of the MRI signal. These images and/or spectroscopy, when interpreted by a trained physician, provide information that may be useful in diagnosis.
- Registration Date
- Sep 15, 2022
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