(92 days)
The MRI system is indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast 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 new Vantage Titan (Model MRT-1504/U4) MRI System is comparable to the current 1.5T Vantage Titan MRI System. The Vantage Titan uses the same magnet as the current Vantage Titan (K080038). However, the following modifications have been added: a redefinition of gradient strength, magnet cover and cabinet's configuration changes. In addition, two applications software: Diffusion Tensor Tractography (DTT), and PaceMaker.
This 510(k) premarket notification describes modifications to an existing MRI system (Vantage Titan) rather than a new AI medical device requiring extensive performance studies. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards for MRI systems, rather than clinical performance metrics for an AI algorithm.
Here's a breakdown of the provided information, framed to address your questions where possible:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (New Vantage Titan MRT-1504/U4) |
|---|---|---|
| Safety Parameters | Static field strength | 1.5T |
| Peak and A-weighted acoustic noise | 106.2 dB (A-weighted), 115.4 dB (peak) | |
| Operational modes | 1st operating mode | |
| Safety parameter display | SAR, dB/dt | |
| Operating mode access requirements | Allows screen access to 1st level operating mode | |
| Maximum SAR | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2002)) | |
| 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.