(15 days)
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
- Fluid Visualization
- 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging
- Blood Oxygenation Level Dependent (BOLD) imaging
- Perfusion / Diffusion Imaging
- Proton Spectroscopy
The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.
The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.
- Gantry bore diameter has been increased from 600mm to 690mm at bore center.
- Maximum power of RF amplifier has been increased from 20KW to 35KW.
- RF amplifier cabinet has been added.
- Gradient power supply has been modified to increase the output current from 300A to 550A.
- Transformer cabinet has been modified to cover the system power requirement.
The provided 510(k) Premarket Notification for the Toshiba Vantage Titan MR system (K080038) does not describe acceptance criteria or a study proving that the device meets those criteria in the context of device performance regarding image quality or clinical efficacy.
Instead, this submission is centered around demonstrating substantial equivalence to a previously cleared predicate device (EXCELART Vantage Atlas-X, K063361), following modifications to hardware and software. The primary focus is on ensuring that the modifications do not alter the system's safety parameters or intended use, and that imaging performance remains equivalent to the predicate.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from predicate K063361, assumed to be met by Vantage Titan) | Reported Device Performance (Vantage Titan) |
|---|---|---|
| Safety Parameters | ||
| Static field strength | 1.5 T | Same (1.5 T) |
| Peak and A-weighted acoustic noise | 110 dB (A-weighted) | Same (110 dB) |
| Operational modes | 1st operating mode for dB/dt and SAR | Same (1st operating mode) |
| Safety parameter display | SAR, dB/dt | Same (SAR, dB/dt) |
| Operating mode access requirements | Allows access to 1st level operating mode | Same (allows access to 1st level operating mode) |
| Maximum SAR | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2002)) | Same (4W/kg for whole body) |
| 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.