(83 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce General Purpose diagnostic images, that can be interpreted by a trained physician.
GPF-29 General Purpose Coil Set MRI RF Coil
This document is a 510(k) clearance letter from the FDA for a General Purpose Coil Set MRI RF Coil. It does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices, which means the FDA has determined it is as safe and effective as a device already on the market. This type of clearance typically relies on demonstrating equivalence through comparison to an existing device, rather than requiring new, detailed performance studies with acceptance criteria as would be found in a PMA (Premarket Approval) application.
Therefore, I cannot extract 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.