(113 days)
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique 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 yield information that can be useful in diagnosis.
The Vantage Galan 3T (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Galan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Galan 3T provides the maximum field of view of 50 x 50 x 45 cm. The 3T Vantage Galan MRI System is comparable to the current 3T Vantage Titan MRI System (K152371), cleared October 23rd, 2015 with the following modifications.
The provided text is a 510(k) Premarket Notification for the Toshiba Vantage Galan 3T MRI System. This document asserts substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or specific studies proving device performance against those criteria as would be found in a clinical study report. Therefore, I cannot extract the information required in your request.
The document states:
- "No change from the previous predicate submission, K152371." regarding imaging performance parameters.
- "The test methods used are the same as those submitted in the previously cleared submissions (K152371)." regarding design control activities.
- "Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."
This indicates that the device's performance is asserted to be equivalent to the predicate device and relies on previous testing and adherence to standards rather than new, detailed performance studies for this specific submission.
Therefore, for the specific questions regarding acceptance criteria, reported performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, the information is not present in the provided document.
§ 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.