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Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial. coronal, sagittal, and obligue images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

• · Proton density (PD) (also called hydrogen density)
• · Spin-lattice relaxation time (T1)
• · Spin-spin relaxation time (T2)
• · Flow dynamics
• · Chemical Shift

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis.

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This document is a 510(k) clearance letter for the Vantage Elan 1.5T, MRT-2020, M-Power GX, a Magnetic Resonance Diagnostic Device. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. The document focuses on the regulatory clearance and indications for use, without detailing the performance testing or clinical studies conducted to demonstrate substantial equivalence.

Therefore, I cannot extract the requested information from the provided input.

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