(24 days)
The eCoil Imaging System for Philips MR scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device.
The MEDRAD eCoil Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. The eCoil Imaging System for Philips MRI scanners is a receive-only coil. The interface device provides interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems.
The provided text is a 510(k) summary for the MEDRAD eCoil Imaging System for Philips. It describes the device's intended use and compares it to a predicate device. However, it does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot provide the requested table and details because the information is not present in the provided document.
This document is a regulatory filing focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance study results against specific acceptance criteria.
§ 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.