(26 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.
Model HNC-127-INT Neurovascular Array Coil
This document is a 510(k) clearance letter from the FDA for a medical device, specifically an MRI coil. It does not contain the requested information regarding acceptance criteria, study data, or ground truth establishment for an AI/ML powered device.
The letter confirms that the Model HNC-127-INT Neurovascular Array Coil is substantially equivalent to legally marketed predicate devices and can be used to produce diagnostic images of the head and neck. It outlines regulatory requirements for the device but does not describe any performance studies or acceptance criteria that would be relevant to an AI/ML powered device.
Therefore, I cannot provide the requested information from the provided text.
§ 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.