(17 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce images that can be interpreted by a trained physician.
HRK-123 Knee Array Coil
I am sorry, but the provided text from the FDA Pre-Market Notification (510(k)) K050299 for the HRK-123 Knee Array Coil does not contain information about acceptance criteria or a study that proves the device meets those criteria.
This document is a letter from the FDA granting substantial equivalence to the device, allowing it to be marketed. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include details of the performance testing, clinical studies, or specific acceptance criteria that would be relevant to the questions asked.
Therefore, I cannot provide the requested information based on the input 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.