The Vantage Galan 3T system is a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. The system is capable of non-contrast enhanced imaging, such as MRA and MRI, and can be used to produce images that exhibit nuclear magnetic resonance (NMR) properties.
Classification and Device Name
The Vantage Galan 3T system is classified as a Class II product under 21 CFR 892.1000. The device is a Magnetic Resonance Diagnostic Device, and its trade name is Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR.
Indications for Use
The Vantage Galan 3T system is indicated for use as a diagnostic imaging modality that produces cross-sectional images of the head or body. The system can be used to produce images that display anatomic structures, such as organs and tissues, and can be used to evaluate the structure and function of organs and tissues.
Manual:
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