(336 days)
Vantage Titan 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 Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 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 Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.
The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.
- . Field strength of magnet has been changed to 3T.
- . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
- . Number of RF amplifier channels is increased from 1 to 2.
- Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
- Software platform has been changed. .
Below is an analysis of the provided text regarding the Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T.
Device Name: Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a comparison study for regulatory clearance (510(k) submission) to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy metrics. The "acceptance criteria" here are based on safety parameters outlined by recognized consensus standards and a qualitative assessment of imaging performance.
| Acceptance Criteria (Predicate Device K080038) | Reported Device Performance (Vantage Titan 3T) |
|---|---|
| Safety Parameters: | |
| Static field strength: 1.5 T | 3T (Change accepted) |
| Peak and A-weighted acoustic noise: | 111.8 dB (A-weighted) |
| 121.3 dB (peak) | |
| 105.7dB (A-weighted) |
115.7dB (peak) | (Higher, but implied within acceptable safety limits for 3T, compliance to IEC 60601-2-33) |
| Operational modes: 1st operating mode (SAR, dB/dt display, access req.) | Same |
| Maximum SAR: 4 W/kg for whole body (1st operating mode, IEC 60601-2-33) | Same |
| Maximum dB/dt:
§ 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.