(22 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the spine that can be interpreted by a trained physician.
Model CTL-63-8 Cervical/Thoracic/Lumbar Array Coil
I am unable to provide a description of the acceptance criteria and study as the provided text is a 510(k) clearance letter and does not contain the specific details about device performance, study design, or ground truth establishment. This document only confirms the FDA's regulatory clearance for the device Model CTL-63-8 Cervical Thoracic/Lumbar Array Coil based on substantial equivalence to a predicate device.
§ 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.