(218 days)
The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.
The Quantitative MT Analysis option uses MTC images created by an MR system and transferred to the EasyVision. The image contrast can be changed by calculating the ratio (based on (MT image- non-MT image)/MT image)) of the scans with and without the MT effect. The resultant image represents the percentile MT effect. The image contrast therefore becomes independent of the T1 (spin-lattice) and T2 (spin-spin) relaxation times and is defined by the MT effect alone.
The provided text does not contain information regarding acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Philips Easy Vision Family Workstation Option Quantitative MT Analysis Package, primarily focusing on its description, intended use, and substantial equivalence to a predicate device, as determined by the FDA.
Therefore, I cannot provide the requested information in the specified format from the given text.
§ 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.