(77 days)
Anatomy: head, limbs, spine, torso; Nuclei: H-1; Diagnostic uses: Imaging
Magnetic Resonance Diagnostic Device.
Here's an analysis of the provided text regarding the IMIG-MRI device, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Head Coil) | Reported Device Performance (Head Coil) | Acceptance Criteria (Body Coil) | Reported Device Performance (Body Coil) |
|---|---|---|---|---|---|
| Signal-to-Noise Ratio (S/N) | S/N | > 32 | > 32 (implied, no specific value given) | > 31 | > 31 (implied, no specific value given) |
| Uniformity | Uniformity |
§ 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.