Overview
The Vantage Galan 3T is a Magnetic Resonance Diagnostic Device (MRDD) designed for diagnostic imaging, producing cross-sectional images of the head or body.
Indications for Use
The device is indicated for use as a diagnostic imaging modality, capable of non-contrast enhanced imaging, and can be used with contrast agents depending on the region of interest.
The system is classified as a Class II device under 21 CFR 892.1000 and has been determined to be substantially equivalent to legally marketed predicate devices.
Manual:
Download: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR User Manual
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