(78 days)
Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR Fluoroscopy.
The MRT-35A v9.0 is a modification of the MRT-35A system which uses a 0.35T superconducting magnet. The MRT-35A v9.0 is an incremental upgrade to an MRT-35A system which is configured with version 8 hardware and software. The 9.0 upgrade replaces the version 8 computer system. The computer architecture, operational characteristics and user software follow the same design considerations cleared by Flexart™ and Visart™ systems. This 9.0 upgrade makes no change to the MRT-35A version 8 series magnet, gradient system or coil set.
Here's a breakdown of the acceptance criteria and study information for the MRT-35A v9.0 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MRT-35A v9.0 are implicitly defined by its equivalency to previously cleared devices (MRT-35A v8.0 and Flexart™) and its demonstrated adherence to "consensus standards requirements" for image quality. The performance is reported by comparing key safety and image performance parameters to these predicate devices.
| Acceptance Criteria Category | Specific Parameter | Acceptance Criterion (Implicitly based on Predicate Device Performance) | Reported MRT-35A v9.0 Performance |
|---|---|---|---|
| Safety Parameters | Maximum static field strength | 0.35 T (MRT-35A v8.0) / 0.5 T (Flexart™) | 0.35 T |
| Rate of change of magnetic field | 6.83 T/sec (MRT-35A v8.0) / 11 T/sec (Flexart™) | 6.83 T/sec | |
| Max. radio frequency power deposition | 0.34 W/kg (MRT-35A v8.0) / |
§ 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.