(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck when interpreted by a trained physician.
Model NVA-127-8-A Neurovascular Array Coil
This document is a 510(k) premarket notification approval letter for a Magnetic Resonance (MR) diagnostic device. It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. The letter confirms substantial equivalence to a predicate device but does not detail performance data, sample sizes, expert qualifications, or ground truth methodologies.
§ 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.