(51 days)
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.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.