MagicScan-1.5, GreenMR Serenity 1.5T
Xingaoyi Medical Equipment Co.,LtdThe MagicScan-1.5 and GreenMR Serenity 1.5T are MRI scanners that create detailed cross-sectional images of the body, head, and extremities. These images help doctors diagnose various conditions by providing clear views of internal structures.
Intended Use
The MagicScan-1.5, GreenMR Serenity 1.5T system is indicated for use as a Magnetic Resonance Imaging System that produces sagittal, transverse, coronal, and oblique cross-sectional images to display internal anatomical structure and/or function of the head, body and extremities, assisting diagnosis when interpreted by a trained physician. Contrast agents may be used depending on the region of interest.
Technology
The system is a 1.5T superconducting MRI scanner with a 60cm bore, consisting of a magnet, RF amplifiers, coils, patient table, spectrometer, computer, signal and equipment cabinets, and a power system. It uses NEMA and DICOM standards and is available in two cooling configurations—one with liquid helium, one without. The system includes multiple receiver coils for various body parts and supports high gradient amplitudes and slew rates, enhancing image quality.
Performance
The device was tested for biocompatibility, cleaning/disinfection, and thermal, electrical, electromagnetic, and mechanical safety, complying with applicable standards (IEC 60601-1, IEC 60601-2-33, NEMA MS series, DICOM, and others). No clinical studies were required; all acceptance criteria were met, confirming the device meets its intended use and is substantially equivalent in safety and effectiveness to the predicate.
Predicate Devices
No predicate devices specified
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