(89 days)
- · is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems
- · is a non-invasive triglyceride fat fraction calculation
- · is a 3D, single breath-hold acquisition and reconstruction technique
- · allows for water-fat separation generating Water-only, Fat-only images as well as Out-phase and In-phase images
- · is indicated for magnetic resonance imaging of the liver
mDIXON-Quant acquisition and reconstruction is based on the mDIXON product developed previously. Acquisition relies on a gradient echo acquisition (FFE) including a large number of echoes (6 or more). Furthermore, mDIXON-Quant reconstruction includes the use of multiple spectral peaks of triglyceride fat, correction of the T2* confounding effect and reduction of T1 bias.
mDIXON-Quant allows for water-fat separation and generates Water-only, Fat-only images as well as Out-phase and In-phase images synthesized from the Water and Fat images. Additionally, mDIXON-Ouant produces images representing triglyceride fat fraction as well as images representing transverse magnetization relaxation.
The feature requires:
- · Specific parameter settings for the mDIXON sequence, within cleared parameter limits, to acquire the MR signals
- · A new calculation function to generate the new images for Fat Fraction, T2 *. This function uses a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
- · The new images need to be stored and displayed with the appropriate labels for Fat Fraction, T2 *, applying the facilities provided by the cleared platform.
Here's a summary of the acceptance criteria and study information based on the provided text for the mDIXON-Quant device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| FF accuracy ±3.5% | FF accuracy is ±3.5% for both field strengths and all possible parameter combinations |
| T2* range and reproducibility 1.5% | T2* range and reproducibility is 1.5% for both field strengths |
| No error messages during Acquisition and Reconstruction testing | No error messages displayed |
| Scan time |
§ 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.