(160 days)
MRI surface coil for peripheral anatomical imaging Anatomical region: Temporo-mandibular joint (TMJ), wrist and other anatomies that are no deeper than 1.5 inches fro the skin.
High Temperature Superconducting (HTS) coil
This 510(k) letter is for a device called "HTS Coil" (High Temperature Superconducting coil). However, the letter only states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information would typically be found in the 510(k) submission itself, which is not provided in this document.
Therefore, I cannot provide the requested information. The provided document is a regulatory approval letter, not a technical report detailing the device's performance studies.
§ 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.